Effect of Exercise Mode in Breast Cancer-Related Lymphedema

NCT04724356 | Completed

• 1 other identifier: 2449PT
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

Gaining a greater understanding of how each exercise mode affects lymphedema, as well as other health-related outcomes will improve exercise prescription guidelines relevant to this specific lymphedema. Therefore, the purpose of this work was to compare the effects of Xbox kinect rehabilitation and resistance exercises on limb volume, symptoms severity, physical function, and quality of life in women with Breast cancer-related lymphedema.

Conditions

Breast Cancer Lymphedema; Quality of Life

Outcome Measures

Primary Outcomes (6)

• Limb volume measurement

  assessed by circumference measurements using a non-elastic tape. Measures started just distal to the metacarpal-phalangeal joints and were taken at 4-cm intervals up the arm until the base of the axilla.

  at baseline

• Limb volume measurement

  assessed by circumference measurements using a non-elastic tape. Measures started just distal to the metacarpal-phalangeal joints and were taken at 4-cm intervals up the arm until the base of the axilla.

  after 8 weeks

• Limb volume measurement

  assessed by circumference measurements using a non-elastic tape. Measures started just distal to the metacarpal-phalangeal joints and were taken at 4-cm intervals up the arm until the base of the axilla.

  after 12 weeks

• Health-related quality of life, Medical Outcomes Study short-form (SF-36)

  assessed using the Medical Outcomes Study short-form (SF-36). Outcomes of physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role emotional and mental health domains were reported as norm-based scores.

  at baseline

• Health-related quality of life, Medical Outcomes Study short-form (SF-36)

  assessed using the Medical Outcomes Study short-form (SF-36). Outcomes of physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role emotional and mental health domains were reported as norm-based scores.

  after 8 weeks

• Health-related quality of life, Medical Outcomes Study short-form (SF-36)

  assessed using the Medical Outcomes Study short-form (SF-36). Outcomes of physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role emotional and mental health domains were reported as norm-based scores.

  after 12 weeks

Secondary Outcomes (9)

• Shoulder range of motion

  at baseline

• Shoulder range of motion

  after 8 weeks

• Shoulder range of motion

  after 12 weeks

• Visual analogue scale

  at baseline

• Visual analogue scale

  after 8 weeks

Study Arms (2)

Virtual Reality Group

EXPERIMENTAL

The Kinect based rehabilitation group received virtual reality therapy using Xbox Kinect-based games, in addition to complex decongestive physiotherapy. The intervention was led once per day, five days a week, over 8 weeks. All participants wearing multilayer bandage or compression stocking during training to avoid exacerbation of the lymphedema in the affected limb.

Other: Virtual Reality

Resistance exercise Group

EXPERIMENTAL

The resistance exercise group received resistance training, in addition to complex decongestive physiotherapy. The intervention was led once per day, five days a week, over 8 weeks. All participants wearing multilayer bandage or compression stocking during training to avoid exacerbation of the lymphedema in the affected limb.

Other: Resistance Exercise

Interventions

Virtual Reality OTHER

Intervention was led once per day, five days a week, over 8 weeks.

Also known as: complex decongestive physiotherapy

Virtual Reality Group

Resistance Exercise OTHER

Intervention was led once per day, five days a week, over 8 weeks.

Also known as: complex decongestive physiotherapy

Resistance exercise Group

Eligibility Criteria

• Age: 30 Years - 65 Years
• Gender Eligibility Details: Breast Cancer-Related Lymphedema
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age more than 30.
• Histological diagnosis of breast cancer at least 1 year prior to the study.
• Clinical diagnosis of unilateral Breast cancer-related lymphedema and obtained medical clearance from their medical oncologists or surgeons.
• Clinical diagnosis of lymphedema was defined as having at least a 5 % inter-limb discrepancy in volume or circumference.

You may not qualify if:

• Unstable lymphedema, receiving intensive therapy within the previous 3 months.
• A musculoskeletal, cardiovascular and/or neurological disorder that could inhibit them from exercising.

Sponsors & Collaborators

• Qassim University: lead
• Cairo University: collaborator

Study Sites (1)

Shorook Physical Therapy Centers

Cairo, 11241, Egypt

Location

Related Publications (4)

• Vicini F, Shah C, Arthur D. The Increasing Role of Lymphedema Screening, Diagnosis and Management as Part of Evidence-Based Guidelines for Breast Cancer Care. Breast J. 2016 May;22(3):358-9. doi: 10.1111/tbj.12586. Epub 2016 Feb 29. No abstract available.

  PMID: 26929240 BACKGROUND

• Morgan PA, Franks PJ, Moffatt CJ. Health-related quality of life with lymphoedema: a review of the literature. Int Wound J. 2005 Mar;2(1):47-62. doi: 10.1111/j.1742-4801.2005.00066.x.

  PMID: 16722853 BACKGROUND

• Aguilar-Lazcano CA, Rechy-Ramirez EJ, Hu H, Rios-Figueroa HV, Marin-Hernandez A. Interaction Modalities Used on Serious Games for Upper Limb Rehabilitation: A Systematic Review. Games Health J. 2019 Oct;8(5):313-325. doi: 10.1089/g4h.2018.0129. Epub 2019 Jul 9.

  PMID: 31287734 RESULT

• Basha MA, Aboelnour NH, Alsharidah AS, Kamel FH. Effect of exercise mode on physical function and quality of life in breast cancer-related lymphedema: a randomized trial. Support Care Cancer. 2022 Mar;30(3):2101-2110. doi: 10.1007/s00520-021-06559-1. Epub 2021 Oct 20.

  PMID: 34669036 DERIVED

MeSH Terms

Conditions

Breast Cancer Lymphedema

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Lymphedema; Lymphatic Diseases; Hemic and Lymphatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Maged Basha, PhD

  College of medical rehabilitation, Qassim University

  PRINCIPAL INVESTIGATOR

• Fatma Alzahraa Kamel, PhD

  Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Physical Therapy, College of Medical Rehabilitation, Qassim University, Saudi Arabia, Qassim, Buraidah.

Study Record Dates

• First Submitted: January 21, 2021
• First Posted: January 26, 2021
• Study Start: January 15, 2019
• Primary Completion: April 20, 2020
• Study Completion: May 5, 2020
• Last Updated: September 16, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 6 months after publication
• Access Criteria: relevance to the topic of the study and approval of all co-authors within 1 month of receiving the request.

Locations

EG (1)