Effect of Lifestyle Intervention vs Physical Therapy Treatment in Patients With Secondary Lymphedema After Cancer

Not Applicable

Completed

• Conditions: Lymphedema, Secondary
• Interventions: Other: Physical therapy treatment; Behavioral: Lifestyle treatment

• Registration Number: NCT04196725
• Lead Sponsor: Inland Norway University of Applied Sciences

Brief Summary

Participants with lymphedema secondary to cancer treatment will participate in a two week rehabilitation programme focusing on physical therapy treatment and a two week programme focusing on physical exercise. The purpose is to assess the effect of the rehabilitation programmes on lymphedema and measures of physical performance.

Detailed Description

Traditionally, physical therapy treatment, e.g. manual lymphatic drainage and compression bandaging is used for treatment of cancer treatment induced lymphedema. Alternatively, lifestyle interventions are used as treatment, with focus on physical exercise. However, the effects of such interventions are scarcely documented. Thus, the purpose of this study is to assess the effect of physical therapy treatment and physical exercise on lymphedema and measures of physical performance.

The study will be performed in a randomized cross-over design, encompassing 26 participants with secondary lymphedema related to cancer treatment. Firstly, half of the participants in the intervention group will be randomized to a two week rehabilitation programme focusing on physical activity while the other half to a rehabilitation programme focusing on physical therapy treatment, and the other way around three months later. In addition. there will be a control group with cancer related lymphedema not participating in any rehabilitation programme. Pre and post of each of the two week rehabilitation periods the following measurements will be performed: The magnitude of lymphedema by volume measurements of the limbs (by DXA); measurements of maximal strength, range of movement, flexibility, balance, physical functionality and questionnaires about perceived health and level of physical activity.

Study Timeline

• Study First Submitted: 2019-11-11
• Status Verified: 2019-12
• Study Start: 2019-12-06
• Study First Submitted QC: 2019-12-10
• Study First Posted: 2019-12-12
• Primary Completion: 2020-04-04
• Study Completion: 2020-04-04
• Last Update Submitted: 2020-05-18
• Last Update Posted: 2020-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• Secondary lymphedema in arm or/and leg related to cancer

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Physical therapy treatment	Physical therapy treatment	-
Lifestyle treatment	Lifestyle treatment	-

Primary Outcome Measures

Name	Time	Method
Lymphedema	Change from before to the end of each of the two week rehabilitation programmes.	Ratio of the volume of affected limb vs volume of nonaffected limb measured by DXA

Secondary Outcome Measures

Name	Time	Method
Self perceived health	Measured immediately before and at the end of each of the two week rehabilitation programmes.	Perceived health assessed by questionnaire
Flexibility in shoulder	Measured immediately before and at the end of each of the two week rehabilitation programmes.	Back scratch test
Test of physical functionality	Measured immediately before and at the end of each of the two week rehabilitation programmes.	Stand up and walk test
Maximal strength	Measured immediately before and at the end of each of the two week rehabilitation programmes.	In handgrip and knee-extension
Balance	Measured immediately before and at the end of each of the two week rehabilitation programmes.	One leg balance test
Flexibility in hip and back	Measured immediately before and at the end of each of the two week rehabilitation programmes.	Sit and reach test
Range of joint movement in the elbow, degrees of movement measured with a protractor	Measured immediately before and at the end of each of the two week rehabilitation programmes.	Range of joint movement in the elbow
Range of joint movement in the knee, degrees of movement measured with a protractor	Measured immediately before and at the end of each of the two week rehabilitation programmes.	Range of joint movement in the knee
Level of physical activity	Questionnaire will be completed immediately before the rehabilitation programmes, assessing the level of physical activity the prior three months.	Level of physical activity assessed by questionnaire

Trial Locations

Locations (1)

Inland Norway University of Applied Sciences; 🇳🇴 Lillehammer, Norway