Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201803003078232 Date of Approval: 12/02/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Resistance Training and Compression Garment in the Management of Breast Cancer-Related Lymphedema
Official scientific title Role of Low-Intensity Resistance Training and Compression Garment in the Management of Breast Cancer-Related Lymphedema: a single-blinded randomized controlled trial
Brief summary describing the background and objectives of the trial The role of compression garments during exercise is not clearly recognized. Recent systematic reviews and clinical trials [27-30] failed to provide adequate evidence and are unable to support or refute the use of compression garment during exercising. On the other hand, the varied effects of compression use during exercising include reducing limb volume to causing temporary increases in swelling [27-29]. The controversy of the results from previous studies may be due to the use of single bouts of exercise versus regular exercises, lack of sampling calculation, and absence of blinding and limited follow-up periods [28-33]. The National Lymphedema Network (NLN) currently supports the use of compression garment during exercise in patients with lymphedema. The compression garment fitting should be handled professionally, using at least Class I compression of 20-30 mmHg for lymphedema in the upper extremity [34]. Therefore, the purpose of this study was to evaluate the effect of exercise alone or when combined with compression garment on limb volume, self-reported lymphedema symptoms; pain, feeling of heaviness, and tightness, and shoulder mobility in women with BCRL.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied breast cancer related lymphedema,Cancer
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 05/02/2015
Actual trial start date 07/06/2015
Anticipated date of last follow up 27/07/2017
Actual Last follow-up date 30/01/2018
Anticipated target sample size (number of participants) 42
Actual target sample size (number of participants) 36
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised The participants were randomly assigned to either exercises and compression therapy group (ExCom-group) or exercise alone group (Ex-group) using sequentially numbered sealed envelopes. The participants were randomly assigned to either exercises and compression therapy group (ExCom-group) or exercise alone group (Ex-group) using sequentially numbered sealed envelopes. Open-label(Masking Not Used)
Parallel: different groups receive different interventions at same time during study Randomised The participants were randomly assigned to either exercises and compression therapy group (ExCom-group) or exercise alone group (Ex-group) using sequentially numbered sealed envelopes. The participants were randomly assigned to either exercises and compression therapy group (ExCom-group) or exercise alone group (Ex-group) using sequentially numbered sealed envelopes. Open-label(Masking Not Used)
Parallel: different groups receive different interventions at same time during study Randomised The participants were randomly assigned to either exercises and compression therapy group (ExCom-group) or exercise alone group (Ex-group) using sequentially numbered sealed envelopes. The participants were randomly assigned to either exercises and compression therapy group (ExCom-group) or exercise alone group (Ex-group) using sequentially numbered sealed envelopes. Open-label(Masking Not Used)
Parallel: different groups receive different interventions at same time during study Randomised The participants were randomly assigned to either exercises and compression therapy group (ExCom-group) or exercise alone group (Ex-group) using sequentially numbered sealed envelopes. The participants were randomly assigned to either exercises and compression therapy group (ExCom-group) or exercise alone group (Ex-group) using sequentially numbered sealed envelopes. Open-label(Masking Not Used) Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group exercise alone group (Ex-group) 3 times weekly 8weeks Participants in Ex-group were instructed to perform supervised exercises 3 times weekly for a total of eight weeks. The training sessions consist of warm-up periods of 5 minute including aerobic exercise (e.g. cycling or walking), 15 minutes of stretching exercise, and 30 to 45 minutes of a resistances training program. 18 Active-Treatment of Control Group
Experimental Group exercises and compression therapy group (ExCom-group) 3 times weekly 8weeks ExCom-group were instructed to perform supervised exercises 3 times weekly for a total of eight weeks. The training sessions consist of warm-up periods of 5 minute including aerobic exercise (e.g. cycling or walking), 15 minutes of stretching exercise, and 30 to 45 minutes of a resistances training program. The participants in the ExCom-group were instructed to wear their compression garment that 18 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
(1) women ¿18 years old (2) unilateral arm lymphedema with inter-limb difference between (10%-40%) indicated mild to moderate lymphedema (3) have stable lymphedema, defined as the absence of therapist-delivered treatment and no arm infection requiring antibiotics in the previous three months (4) presence of one or more of the following symptoms pain, tenderness and heaviness. (1) evidence of current metastases, cellulitis and active infection (2) clinical and radiological evidence of congestive heart disease, and upper limb deep venous thrombosis (3) paralysis and severe trauma (4) bilateral BCRL (5) previous lymphedema therapy within the last 3 months (6)required medication that might affect lymphedema volume. 18 Year(s) 65 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes local research ethics committee at EL-Mattaria Teaching Hospital.
Ethics Committee Address
Street address City Postal code Country
EL-Mattaria square Cario Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Limb volume measurement using circumference measurements. 1- Baseline (W0), 2- Immediately after intervention at week eight (W8) 3-Follow-up assessment at week 12 (W12),
Secondary Outcome Self-reported lymphedema symptoms Participants were instructed to rate their pain severity, tightness, and heaviness using a 10-cm horizontal line of visual analogue scale (VAS), where one indicates that the symptoms are not present, while 10 is the worst imaginable experience of that symptoms. 1-Baseline (W0), 2-Immediately after intervention at week eight (W8) 3-Follow-up assessment at week 12 (W12),
Secondary Outcome Shoulder range of motion (ROM) A goniometer was used to determine the angles of maximum active abduction, flexion (elevation), and external rotation 1- Baseline (W0), 2- Immediately after intervention at week eight (W8) 3-Follow-up assessment at week 12 (W12),
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
El-Mattaria Teaching Hospital, Mattaria Square Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
self funded
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Rokia M, EL-Sabagh4 4- Physical Therapy department, El-Mattaria Teaching Hospital. Cairo, Egypt Cairo Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Ghada S M Omar1 1-Cairo University, Faculty of Physical Therapy, Physical Therapy Department for Surgery, 7 Ahmad Al- Zayat St., Bain El-Sarayat, Giza 12612, Egypt. Giza 12612 Egypt
Abd¿EL Aziz E, Mersal Surgery department, El-Mattaria Teaching Hospital. Cairo, Egypt Cairo Egypt
Rehab FM Gwada Physical Therapy Department, National Heart Institute, Giza, Egypt Giza Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohammed Omar momarar@cu.edu.eg +2010975553729 7 Ahmad Al-Zayat St., Bain El-Sarayat, Giza
City Postal code Country Position/Affiliation
Giza 12612 Egypt Assistant professore of physical therapy, certified lymphedema therapist
Role Name Email Phone Street address
Public Enquiries Mohammed Omar momarar@cu.edu.eg +2010975553729 7 Ahmad Al-Zayat St., Bain El-Sarayat, Giza
City Postal code Country Position/Affiliation
12612 Egypt Assistant professore of physical therapy, certified lymphedema therapist
Role Name Email Phone Street address
Scientific Enquiries Mohammed Omar momarar@cu.edu.eg +2010975553729 7 Ahmad Al-Zayat St., Bain El-Sarayat, Giza
City Postal code Country Position/Affiliation
Giza 12612 Egypt Assistant professore of physical therapy, certified lymphedema therapist
REPORTING
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