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

Study Overview
=================
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.

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

Conditions
-----------------
Lymphedema, Secondary

Intervention / Treatment
-----------------
* Other: Physical therapy treatment
* Behavioral: Lifestyle treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Secondary lymphedema in arm or/and leg related to cancer Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: 26 participants will be enrolled in the cross over design consisting of two different rehabilitation programme. In addition there will be a parallel control group with 10 participants not participating in any of the rehabilitation programmes.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physical therapy treatment<br> | Other: Physical therapy treatment<br>* Two weeks rehabilitation programme focusing on physical therapy treatment, e.g. manual lymphatic drainage and compression bandaging<br>|
| Experimental: Lifestyle treatment<br> | Behavioral: Lifestyle treatment<br>* Two weeks rehabilitation programme focusing on physical activity<br>|
| No Intervention: Control<br>Parallel control group, not undertaking any treatment and not part of the cross-over design | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lymphedema | Ratio of the volume of affected limb vs volume of nonaffected limb measured by DXA | Change from before to the end of each of the two week rehabilitation programmes. | 

Secondary Outcome Measures

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