Study reference

Study characteristics

Patient characteristics

Intervention (I)

Comparison / control (C)

Follow-up

Outcome measures and effect size

Comments

Singh 2016

A. Jonsson 2014

B. Ahmed 2006

C. Cormie 2013

D. Gautam 2011

E. Johansson 2014

F. Katz 2010

G. Schmitz 2009

H. Hayes 2009

I. Fisher 2014

J. Johansson 2013

K. Loudon 2014

Type of study

Systematic review

Country

Australia

Search date

1 January 2015

Number of included studies

11 studies regarding exercise training

Inclusion criteria

Patients with clinically diagnosed, cancer-related upper or lower lymphedema Intervention studies that involved more than 1 bout of exercise; that is, they involved regular exercise training (>4wk) with lymphedema assessed pre- and postintervention. Studies that involved exercise in addition to other interventions were excluded if the effects of exercise could not be isolated. RCTs, non-RCTs, and single-group pre-post studies were included.

N total

443 participants

A. 35

B. 45

C. 62

D. 32

E. 23

F. 10

G. 141

H. 32

I. 6

J. 29

K. 28

Location of lymphedema

F. Lower extremity.

All other studies includes patients with lymphedema of the upper extremity.

A. Aerobic exercise (n = 35).

B, C, D, E, F, G: Resistance exercise (n = 313).

H. Mixed exercise: aerobic and resistance exercise (n = 32).

I, J, K: Other exercise (I & K = yoga, J = water-based exercise) (n = 63).

Intervention was compared to no exercise, usual care or continued habitual and/or physical activity

Length of follow-up

Not reported. All exercise programs had a duration between 8 weeks and 12 months

Loss to follow up

Not reported

Change in lymphedema (standardized mean difference [95% CI])

Aerobic exercise

-0,17 [-0,64-0,30]

Resistance exercise

-0,08 [-0,27-0,12]

Mixed exercise

0,07 [-0,65-0,78]

Other exercise

-0,07 [-0,56-0,42]

Total all types of exercise

-0,08 [-0,25-0,08]

Change in pain

F. pre-exercise: VAS-Pain 5,8, post-exercise: VAS-pain 5,2, SDs not reported, no statistical analysis performed

K. pre-exercise: VAS-pain 0,99 ± 1,53, post-exercise: VAS-pain 0,80 ± 1,48, p = 0,878

Study reference

Study characteristics

Patient characteristics

Intervention (I)

Comparison / control (C)

Follow-up

Outcome measures and effect size

Comments

Do 2017

Type of study:

RCT

Country

South Korea

Source of funding:

Not reported

Inclusion criteria:

Patients with secondary unilateral lymphedema, after gynaecologic

surgery with pelvic lymph node dissection for cervical, endometrial, or ovarian cancer, that had been diagnosed based on clinical assessment and lymphoscintigraphy findings and 10% volume differences between the legs

Exclusion criteria:

Cancer recurrence

and presence of other diseases (arterial insufficiency, deep vein thrombosis, chronic venous insufficiency, heart or kidney disease, musculoskeletal disease, and neurologic disorder). Patients with

skin problems, such as a scarring, inflammation, or infection.

N total at baseline (n analysed)

44 (40)

Baseline characteristics

Mean age: CDT group 55,9 years, CRCDT group 57,5 years

Mean BMI: CDT group 23,9, CRCDT group 23,7

CDT + Complex rehabilitation (CR). CR consists of stretching, strengthening, core stability exercises, aerobic exercises for 40 min 5 times a week for 4 weeks. During the first 2 weeks, the exercises were supervised by a physical therapist in the rehabilitation room. For the next 2 weeks, the patients were asked to exercise at home and write in the exercise diary.

Complex decongestive therapy (CDT, dr. Vodder method) consisting of:

manual lymphatic drainage (MLD) 5 times a week for 2 weeks, a pneumatic pump device after MLD, compression therapy, skin care,

and remedial exercise. CDT

method) was performed by one certified physical therapist during the

first 2 weeks. For weeks 2–4, the patients themselves performed MLD

and self-bandaging

Length of follow-up:

0 (intervention duration 4 weeks)

Loss-to-follow-up:

4

Affected leg volume mean (SD)

CRCDT

Pre: 9,836.4 (33,204,6)

Post: 93,142.6 (29,388,1)

CDT

95,061,6 ± 19,803,1

91,632,0 ± 17,492

p = 0,900

QoL (EORTC QLQ-C30) mean (SD)

CRCDT

Pre: 60,3 (19,4)

Post: 76,6 (32,2)

CDT:

Pre: 62,8 (26,9)

Post: 69,5 (18,1)

p = 0,300

Physical domain EORTC QLQ-C30 mean (SD)
CRCDT

Pre: 59,5 (15,1)

Post: 86,6 (12,2)

CDT:

Pre: 55,7 (22,4)

Post: 70,9 (16,6)

p = 0,001

Pain & fatigue symptom scale EORTC QLQ-C30 mean difference [95% CI]

Fatigue

CRCDT: -34,7 [-47,9 to -21,54]

CDT: -13,0 [-27,8 to 1,8]

P = 0,014

Pain

CRCDT: -28,6 [-44,4 to -12,8]

CDT: -19,7 [-35,1 to -4,1]

P = 0,189

Determination of volume not clearly reported; unit of volume not reported

Study reference

Study characteristics

Patient characteristics

Intervention (I)

Comparison / control (C)

Follow-up

Outcome measures and effect size

Comments

Ergin 2017

Type of study:

RCT

Country

Turkey

Source of funding:

Not reported; no competing financial interests declared

Inclusion criteria:

- Suffered from primary or secondary unilateral lower extremity lymphedema.

- Had undergone or completed the minimum 2 weeks intensive phase of CDP in the past.

- Received approval to participate in ALT by their physician.

- Was a volunteer.

- Was older than 18 years of age.

Exclusion criteria:

- Had undergone sentinel lymph node biopsy.

- Had active metastatic disease.

- Had cardiac insufficiency.

- Had acute infection anywhere in the body.

- Had urinary incontinence.

- Had hydrophobia

- Had psychological disease.

N total at baseline (n analysed)

63 (57)

Baseline characteristics

Mean age

ALT group: 44,50 ± 13,69 years.

Control group: 47,66 ± 16,82 years

Mean BMI

ALT group: 29,43 ± 7,90 kg/m2

Control group:  29,64 ± 8,07 kg/m2

Aqua lymphatic therapy (ALT): Intervention program for 6 weeks with 12 sessions (twice a week) visit to the pool for gentle exercises performed in a low-resistance manner, consisting of breathing exercises, proximal movements of chest and trunk and manual techniques, followed by self-massage and distal movements that involve the hips, knees, ankles, toes. Then, remedial exercises were performed from proximal to distal.

Intervention program for 6 weeks with 12 sessions (twice a week) visit to lymphedema unit for self-lymphatic drainage and remedial exercises (proximal to distal). Each session lasts 45-60 minutes. Self-management during rest of the week.

Length of follow-up:

0 (duration of intervention: 6 weeks).

Loss-to-follow-up:

6 did not complete intervention.

Compared with the volume changes between the groups, a reduction of VT, V3, V4, V5, V6, V7, V11, and V12 volumes was statistically higher in the ALT group than the control group ( p < 0,05).

Volumetric measurement (measured by difference in overflowing watercontainer between both legs) Median (minimum-maximum)

ALT group:

Before therapy 1500ml (890-4300)

After therapy: 1170ml (180-4150)

P < 0,001

Control group:

Before therapy 1595ml (775-4170)

After therapy 1540ml (770–4680)

P < 0,001

ALT vs. Control group not reported

Volume Total (circumference on 12 locations with Frustum Formula) and were added together to calculate limb volume: V1 + V2 + … + V12 = VT)

ALT group:

Before therapy 8322,29 (6205,38–22888,96)

After therapy  7596,31 (6172,15–21537,78)

P < 0,001

Control group:

Before therapy: 8609,80 (5409,41–24101,08)

After therapy: 8242,44 (5413,47–23322,64)

P = 0,019

Compared with

The reduction of VT was statistically higher in the ALT group than the control group ( p < 0,05).

- The intervention is poorly explained, making it hard to reproduce the study

- Between-group comparison inadequate and poorly done; only significant results are shown and only a p-value is reported. Authors make it look as if ALT group decreases volume, but do not report results for the volumetric measurement comparison.

Study reference

Study characteristics

Patient characteristics

Intervention (I)

Comparison / control (C)

Follow-up

Outcome measures and effect size

Comments

Kilbreath 2020

Type of study:

RCT

Country

Australia

Source of funding:

National Health and Medical Research Grant

Inclusion criteria:

Women were

eligible to participate if they: were aged ≥ 18 years; had undergone surgery for breast cancer that included wide local excision and axillary surgery; reported having breast oedema for longer than 3 months in which the intensity of the breast related symptoms such as heaviness and/or discomfort were ≥ 3 on a 10-cm visual analogue scale at enrolment into the study.

Exclusion criteria:

Women were excluded if, within the previous 3 months, they had: undergone intensive lymphoedema therapy (i.e. decongestive therapy); experienced infections in the lymphoedematous

regions requiring antibiotic treatments; and/or had experienced exacerbation that led to a change in their activities of daily living. They were also excluded if they had a history of primary lymphoedema, were fitted with a pacemaker, had undergone bilateral axillary dissections,

engaged in regular moderate-to-high intensity exercise, or

had any condition which excluded them from participating in exercise. In addition, women were excluded if they were

pregnant or lactating.

N total at baseline (n analysed):

88 (84)

Baseline characteristics:

Female: 88

Male: 0

Mean age

Years (SD)

Exercise group:

53,7 (10,4)

Control group:

59,5  (8,0)

Exercise group (40)

Participants completed three 1-h exercise sessions per

week for 12 weeks. An Accredited Exercise Physiologist

(AEP), trained by the study AEP with cancer care expertise,

supervised each of the three exercise sessions in the first week and then once weekly thereafter for the duration of the

intervention.

The training session comprised a low intensity warm-up including stretching, 30 min muscular hypertrophy training using free weights and variable resistance machines followed by two 10-min blocks of aerobic training using the stationary bike, treadmill, rower, and/

or cross-trainer. The resistance exercises targeted upper and lower limb muscle groups as well as the abdominal,

chest and back.

Control group (44)

Participants were contacted weekly (during 12 weeks)

to monitor their general health and lymphoedema status, but no advice was provided about exercise.

Length of follow-up:

12 weeks

Loss-to-follow-up:

Exercise group:

2 (4,9%)

(unable to contact (1), readmitted to hospital (1))

Control group:

1 (2,1%)

(unable to contact (1))

Change in lymphedema

Change in BIS ratio

Breast lymphedema:

Exercise group:

-0,127 (IQR -0,335 to 0,051)

Control group:

0,073 (IQR -0,110 to 0,252)

P = 0,018

There was no evidence of a

significant difference between groups in change in BIS ratio

for the arms or legs.

Patient reported outcomes:

Changes in EORTC BR23 score, median (IQR):

Breast:

Exercise group:

-16,7(-25,0 to -8,3)

Control group:

0,0 (-8,3 to 8,3)

P < 0,01

Arm:

Exercise group:

-11,1 (-22,2 to 0)

Control group:

0,0 (-11,1 to 11,1)

P < 0,05

Change in LSIDS score, median (IQR):

Exercise group:

Intensity:

-1,5 (-7,5 to 0)

Distress:

-2 (-10,8 to 0)

Control group:

Intensity:

-5 (-10 to 0,3)

Distress:

-6,5 (-12,3 to -2,8)

No significant difference between groups 

Results of EORTC BR23 and BIS ratio are split in women with breast or arm lymphedema.

Study reference

Study characteristics

Patient characteristics

Intervention (I)

Comparison / control (C)

Follow-up

Outcome measures and effect size

Comments

Luz 2018

Type of study:

Controlled clinical trial.

Country

Brazil

Source of funding:

Not reported.

Inclusion criteria:

adult females (≥ 18 years old), with upper limb lymphedema (difference in arm circumference of at least two centimeters at two different sites), resulting from unilateral surgery for breast cancer treatment, available to participate in the study twice a week for eight

weeks,

Exclusion criteria:

Bilateral breast cancer; renal dysfunction; acute inflammation; deep vein

thrombosis; heart disease; skin infections; metastatic lymphedema; or had participated in any treatment involving the reduction of lymphedema in the previous three months. Stage 3 lymphedema.

N total at baseline (n analysed)

42 (42)

Baseline characteristics

Mean age 59,2 years

Complex physical therapy (CPT) consisting of MLD, multilayer bandage compression therapy, skin care, regular exercises twice a week during 8 weeks + strength training (ST) consisting of a muscular strengthening protocol twice a week during 8 weeks. Exercise sessions consisted of heating & circumduction movements of shoulders; then, shoulder abduction, protraction & retraction of shoulder blades, shoulder flexion, shoulder AB, external and internal rotation, elbow flexion, fist flexion and extension, elbow extension, press/move the ball (all with halters or TheraBands), followed by relaxation.

CPT alone

Length of follow-up:

0

Intervention duration: 8 weeks

Loss-to-follow-up:

 0

Volume measured by tape measure and using a formula (Lanza 2015) to calculate volume

CPT group: first session mean 2272 (SD 434,05) mm, 16^th session; 2153 (SD 438,05) mm.

ST group: first session mean 2626 (SD 507,52 mm), 16^th session 2329 mm (SD 472,85)

p = 0,555

Strength measured by peak-forece during 5 second contraction; no significant difference between strength training group and control group

Shoulder, elbow and wrist range of motion: decreased endorotation in strength training group; no difference in other shoulder movements or wrist/elbow mobility.

Study reference

Study characteristics

Patient characteristics

Intervention (I)

Comparison / control (C)

Follow-up

Outcome measures and effect size

Comments

Schmitz 2019

Type of study:

RCT

Country

USA

Source of funding:

Grants from the National Institute of Health, National Centre for Advancing Translational Sciences of the National Institutes of Health, Comprehensive Cancer Centre Support Grants of the National Cancer Institute, National Institutes of Health and the Commonwealth of Pennsylvania, National Cancer Institute, National Institute of Mental Health. Compression garments were donated by BSN

Medical, and discounted meal replacements were

provided by Nutrisystem,

Inclusion criteria:

Women who were diagnosed with BCRL according to the Common Toxicity Criteria for Adverse Events, version 4 (National Cancer

Institute),22 or who had a previous diagnosis of lymphedema. In addition, eligible participants were cancer free, 6 months or more posttreatment, had a BMI of 25 to 50  (overweight or obese), were able to walk unaided for more than 6 minutes.

Exclusion criteria:

Participants had no medical conditions prohibiting exercise, no plans for additional surgery, no self-report of engaging in resistance exercise or in 3 or more weekly aerobic sessions over the previous 12 months, no current use of any weight loss medication, no weight loss greater than 4,5 kg within the previous 3 months, and no history of bariatric surgery.

N total at baseline (n analysed):

351 (280)

Exercise group (90):

Participants were taught resistance

exercises in groups of 2 to 6 women, once a week for 90 minutes. After six weeks classes were replaced by behavioural support telephone calls.

Women were instructed to exercise twice a week and walk 180 min. a week.

Exercise + weight loss group (87)

Control group (87):

All groups received standard lymphedema care and compression garments. 

Weight loss group (87):

Participants

attended 24 weekly sessions led by a registered dietitian in

groups of 2 to 12 women. From weeks 25 through 52, groups met monthly for weighins

and additional behavioural modification lessons.

Length of follow-up:

52 weeks

6 wk group training, thereafter home-based.

Loss-to-follow-up:

Exercise group:

22 (24,4%)

Weight loss group:

16 (18,4%)

Exercise + weight loss group:

19 (21,8%)

Control group:

14 (16,1%)

Interlimb volume difference (%) after 52 weeks, measured with perometry. Mean (SD)

Exercise group:

-0,3% (5,4)

Exercise vs control:

P = 0,96

Weight loss group:

0.2% (5,0)

Weight loss vs control:

P = 0,51

Exercise + weight loss group:

0,4% (5,3)

Combination vs control: p = 0,40

Control group:

-0,3% (5,7)

Clinical characteristics of lymphedema, change in CLUE assessment tool score after 52 weeks. Mean (SD):

Exercise group:

-2,54 (13,20)

Exercise vs control:

P = 0,53

Weight loss group:

-3,54 (12,88)

Weight loss vs control:

P = 0,21

Exercise + weight loss group:

-3,84 (10,09)

Combination vs control: p = 0,16

Control group:

-1,40 (11,10)

Self-reported symptoms using the Norman Lymphedema survey, change in score after 52 weeks. Mean (SD):

Overall extremity:

Control group:

 −0,39 (2,33)

Exercise group:

−0,12 (2,14)

vs control: P = 0,46

Weight loss group:

−0,57 (2,47)

vs control: P = 0,61

Exercise + weight loss group:

−0,62 (2,38)

vs control: P = 0,52

Overall breast/torso

Control group:

 −0,13 (1,17)

Exercise group:

 0,03 (1,25)

vs control: P = 0,36

Weight loss group:

−0,01 (1,23)

vs control: P = 0,51

Exercise + weight loss group:

−0,01 (1,06)

vs control: P = 0,53

Symptoms (range, 0-14), No.

Control group:

−0,84 (3,11)

Exercise group:

−1,27 (3,01)

vs control: P = 0,34

Weight loss group:

 −1,11 (2,88)

vs control: P = 0,56

Exercise + weight loss group:

−1,42 (2,92)

vs control: P = 0,20

Symptom severity (range, 0-4)

Control group:

 −0,25 (0,97)

Exercise group:

−0,28 (0,97)

vs control: P = 0,84

Weight loss group:

−0,30 (0,86)

vs control: P = 0,74

Exercise + weight loss group:

−0,35 (0,93)

vs control: P = 0,50

Study reference

Study characteristics

Patient characteristics

Intervention (I)

Comparison / control (C)

Follow-up

Outcome measures and effect size

Comments

Sener 2017

Type of study:

RCT

Country

Turkey

Source of funding:

Not reported

Inclusion criteria:

Presence mild, moderate or severe lymphedema in upper extremities

after breast cancer treatment. Aged over 18 years.

Exclusion criteria:

Presence of metastatic breast cancer. Presence of diagnosis of severe heart failure and / or arrhythmia. Presence of infection in the affected limb. Presence of severe psychological disorders. Presence of severe pain of unknown cause in the axillary region. Presence of musculoskeletal problems in the upper extremity before the treatment of breast cancer. Presence of other health problems that would prevent participation

in the evaluation and treatment program.

N total at baseline (n analysed)

62 (60)

Baseline characteristics

Age (SD)

Pilates group: 53,17 (7,66).

Control group:

54,03 (12,57).

BMI (SD)

Pilates group: 28,54 (4,51).

Control group:

30,35 (4,99).

Pilates exercises and

Postures + MLD, skincare, shoulder exercises

Exercises were performed in groups of 5-8 persons 3 times a week for 8 weeks and supervised by a physiotherapist. During training, the patients were taught how to create lumbopelvic stability (core stabilization), which is the basis for Pilates exercises, and spinal stabilization and appropriate posture techniques. Each patient was taught how to create lumbar and spinal stabilization in the prone, supine, and side-lying positions using a stabilizer. After four weeks an elastic resistance band was added. Participants were also asked to practice a home program every

day that included manual lymphatic drainage training, wall extension, and Wand exercises used to improve shoulder flexibility and skin care

training.

Lumbopelvic stability + MLD, skincare, shoulder exercises

Participants were taught how to protect core

stabilization while performing activities of daily living and they were

recommended to maintain a home exercise program.

The participants were given a brochure that described these

exercises and were recommended to repeat these exercises at least 10 times. They were also advised to pay attention to skin care and to walk 1 hour every day. The participants were followed up through telephone

calls.

Length of follow-up:

0 (intervention duration: 8 weeks; final measurements at wk 8).

Loss-to-follow-up:

2

Upper limb circumferences measured with a tape measure starting from the proximal nail fold of the middle finger up to the armpit at 5 cm intervals when the patient was in the supine position.

A significant difference was found on 12/13 measuring points.

Grip strength:

Mean difference in pilates group 2,27 [95% CI -1,06-5,60] kg, control group 1,17 [95% CI -1,95-429] kg, p < 0,05) 

Quality of life

EORTC QLQ-BR23

Post treatment:

Pilates group: 38,51 (8,42)

Control group: 28,37 (7,48)

P = 0,94

Study reference

Study characteristics

Patient characteristics

Intervention (I)

Comparison / control (C)

Follow-up

Outcome measures and effect size

Comments

Tidhar 2010

Type of study

RCT

Country

Israel

Source of funding:

Not reported

Inclusion criteria:

Women who suffered from unilateral lymphedema due to breast cancer surgery and had undergone axillary lymph node dissection, women who undergone or completed the intensive phase of CPT in the past and were at least 2 weeks into the self-management stage of therapy, women who received approval to participate in ALT by their physician.

Exclusion criteria:

Women who had undergone sentinel lymph node biopsy, had active metastatic disease.

N total at baseline (n analysed)

48 (48)

I: 16

C: 32

Baseline characteristics

Age (SD)

I: 56,2 (10,7)

C: 65,5 (8,8)

BMI >25

I: 13 (81,3)

C: 24 (75,0)

History with chemotherapy or/and radiotherapy was higher in the control group.

Weekly session of ALT + advise to carry on with self-management.

Exercises were performed in a 1.2-m deep pool with a temperature between 32°C and 33°C.  Each session lasts 45 min, once a week. Type of exercises: (1) breathing exercise (2) proximal movements of chest and shoulder girdle  and manual techniques of self-massage (3) vertical positioning of the arm in the water and performing self-massage and distal movements that involve the elbows, wrists, and fingers

Self-management

Length of follow-up:

12 weeks

Loss-to-follow-up:

0

Discontinued intervention:

1

Lymphedema relative volume (LVR), calculation: ((EV) x 100 /volume contra lateral arm)

End of the study (mean, SD)

I: 14,7 % (23,9)

C: 11,8 % (15,3)

P = 0,87

QoL (ULL27), change scores (mean (SD)):

Physical dimension:

I: -2,5 (8,9)

C: 0,4 (9,8)

P = 0,39

Emotional dimension:

I: -3,5 (6,4)

C: 0,5 (4,4)

P = 0,03

Social dimension:

I: -1,4 (3,2)

C: 1,7 (4,0)

P = 0,01

Artikel

Reden van exclusie

Baumann 2018

Voldeed niet volledig aan PICO.

Bracha 2012

Follow-up te kort

Buchan 2016

2 typen exercise vergeleken en dus niet vergeleken met ‘geen behandeling of placebo’.

Chan 2010

Patiënten at risk voor lymfoedeem

Devoogdt 2010

Patiënten at risk voor lymfoedeem

Fong 2014

Follow-up te kort

Hasenoehrl 2019

Recentere update beschikbaar

Hasenoehrl 2020

Deel patiënten at risk voor lymfoedeem

Iyer 2018

Interventie is geen oefentherapie

Jeffs 2012

Te weinig deelnemers, interventie is geen oefentherapie

Johnson 2020

Uitkomstmaten komen niet overeen

Keilani 2015

Gemengde populatie lymfoedeem en patiënten at risk voor lymfoedeem

Kwan 2011

Gemengde populatie lymfoedeem en patiënten at risk voor lymfoedeem

Kim 2010

Follow-up te kort

Kizil 2018

Type oefening (passief)

Letillier 2014

Weinig deelnemers (25) en 2 types exercise vergeleken; en niet vergeleken met placebo/ usual care

Lindquist 2015

Follow-up te kort (10 weken)

Loudon 2014

Te weinig deelnemers

Loudon 2018

Te weinig deelnemers, interventie is geen oefentherapie

McClure 2010

Interventie is geen oefentherapie

McNeely 2011

Recentere SR’s beschikbaar

Oremus 2012

Te beknopte weergave van studies en resultaten, type exercise weinig toegelicht

Panchik  2018

Review, onvoldoende gegevens primaire studies

Paramandam 2014

Gemengde populatie lymfoedeem en patiënten at risk voor lymfoedeem

Rogan 2016

Geselecteerde studies van te slechte kwaliteit

Tsai 2020

Uitkomstmaat gewichtsafname

Vafa 2020

Interventie is geen oefentherapie

Wanchai 2019

Gemengde populatie lymfoedeem en patiënt at risk voor lymfoedeem

Wei 2019

Interventie is geen oefentherapie

Winkels 2017

Zelfde cohort als Schmitz 2019

Yeung 2017

Betreft alleen Aqua lymfatic therapy

Study reference

(first author, publication year)

Describe method of randomisation¹

Random sequence generation (selection bias)²

(high/unclear/low risk)

Allocation concealment (selection bias)³

(high/unclear/low risk)

Blinding of participants and personnel (performance bias)^4,6

All outcomes

(high/unclear/low risk)

Blinding of outcome assessor (detection bias)^5,6

All outcomes

(high/unclear/low risk)

Incomplete outcome data (attrition bias)⁷

All outcomes

(high/unclear/low risk)

Selective reporting (reporting bias)⁸

(high/unclear/low risk)

Other bias⁹

(high/unclear/low risk)

Do 2017

Participants were  randomly assigned to either the intervention

group or the control group

Low risk

Quote: patients were randomly assigned à probably done

Unclear

Not reported

High risk

Not reported but patients should be able to know in which group they are

Unclear

Not reported

Unclear

Reason for drop-outs (4/44)not reported

Unclear

Low risk

Ergin 2017

After the baseline assessment,

participants were randomly assigned to either the ALT group

or the control group by using the simple random sampling

method.

Low risk

Low risk

Quote: assignment was revealed by an independent researcher who was not involved in the assessment

High risk

Participants and personnel knew which group patients belonged to

Low risk

Quote: The therapist who performed the outcome assessments was unaware of the group allocation throughout the study

Unclear

Quote: two of the ALT and four of the control group patients withdrew

from the study

Reasons for withdrawal were not reported

High risk

Incomplete reporting of results; between group comparison lacks data, only a p-value is mentioned

Low risk

Kilbreath

2020

Following baseline measurements, women were randomly

allocated to either the Exercise group (Exercise) or Control

group (Control). Randomisation was stratified by location

of lymphoedema: breast only versus breast and arm lymphoedema.

The randomisation list was computer generated

in permuted blocks of 4, 6 or 8 by a person not in contact

with the participants. Allocation was concealed inside

sequentially numbered, opaque sealed envelopes and opened

after baseline assessments had been completed.

Low risk

Low risk

High risk

Low risk

Measurements were performed by a research assistant

blinded to group allocation at baseline and at 12 weeks.

Treatment group was coded to enable blinded analysis,

which was by intention to treat.

Low risk

Reasons for loss-to-follow-up are reported and similar in both groups

Unclear

Low risk

Luz 2018

They were divided into two groups

according to the order of admission: the first patient was

allocated to the treatment group, next to the control group

and so on.

High

High

High

Not reported but patients could easily find out whether they are in the strength training group or control group. Personnel should know which groups patients are

Unclear

Not reported

Low

No loss to follow up

Unclear

Low

McLaughlin 2020

Beschrijven, geen RoB (weinig deelnemers, maar zeldzame vorm)

Schmitz 2019

Women were assigned to

4 groups of equal size through a computerized process called

minimization,19,20 in a manner that was unpredictable and concealed

from the study staff members who determined eligibility

Low risk

Low risk

High risk

Low risk

All measurement staff were blinded to the participants’ intervention status. Participants were asked

to avoid divulging their group assignment to outcome assessors

Low risk

Greater losses tofollow-up occurredin the control

group than in the exercise,weight loss, and combined intervention

groups. Rigorous comparisons of baseline

characteristics between those whowere lost to follow-up and

those who completed the study did not reveal any significant

differences. Furthermore, use of multiple imputation analyses

addressed this potential limitation. Notably, results for the

primary outcome remained consistent when they were analyzed

without imputation.

Low risk

Low risk

Sener, 2017

Based on their admission to the clinic without looking at the severity of lymphedema, the patients were asked to draw one of the two

cards colored blue or red, and thus they were assigned to the two

study groups through this simple random sampling method. Those

who drew red cards were assigned to the clinical Pilates exercise group

(n=32) and those who drew blue cards were assigned to the control

group (n=30).

High risk

High risk

High risk

Low risk

Quote: all evaluations were done by another physiotherapist

Low risk

Quote: two patients (from the pilates exercise group) were excluded

from the study because one developed liver metastasis and the other

discontinued treatment.

Unclear

Low risk

Tidhar, 2010

Participants were randomly assigned to either the ALT group or the control group using the block sampling method.

Low risk

Low risk

Quote: Assignment was concealed in sequential opaque envelopes and was revealed by an independent researcher not involved in the assessment

High risk

Low risk

Quote: The therapist who performed the outcome assessments was unaware of the group allocation throughout the study.

Low risk

No loss to follow-up.

Unclear

Low risk

Study

First year, author

Appropriate and clearly focused question?¹

Yes/no

Comprehensive and systematic literature search?²

Yes/partial yes/ no

Description of included and excluded studies?³

Yes/partial yes/ no

Description of relevant characteristics of included studies?⁴

Yes/partial yes/no

Assessment of scientific quality of included studies?⁵

Yes/partial yes/no

Enough similarities between studies to make combining them reasonable?⁶

Yes/partial yes/ no

Potential risk of publication bias taken into account?⁷

Yes/partial yes/ no

Potential conflicts of interest reported?⁸

Yes/partial yes/ no

Singh, 2016

Yes

Clearly stated PICO

Yes

Multiple databases were searched, search strategy was provided, references were checked

No

No list of excluded studies nor reasons for exclusion available

No

Described most relevant characteristics (PICO) in adequate detail, however research designs of included studies were insufficiently described

Yes

The Effective Public Health Practice Project Quality Assessment Tool31 was used to assess study quality and risk of bias by 2 independent authors

Partial yes

Although participants were mostly comparable, the interventions and outcome measurements were sometimes different

Yes

Funnel plots were made and indicated no apparent evidence of publication bias

No