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

Primary Purpose

Lymphedema, Secondary

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Physical therapy treatment
Lifestyle treatment
Sponsored by
Inland Norway University of Applied Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphedema, Secondary

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

-

Sites / Locations

  • Inland Norway University of Applied Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Physical therapy treatment

Lifestyle treatment

Control

Arm Description

Parallel control group, not undertaking any treatment and not part of the cross-over design

Outcomes

Primary Outcome Measures

Lymphedema
Ratio of the volume of affected limb vs volume of nonaffected limb measured by DXA

Secondary Outcome Measures

Maximal strength
In handgrip and knee-extension
Balance
One leg balance test
Flexibility in hip and back
Sit and reach test
Flexibility in shoulder
Back scratch test
Test of physical functionality
Stand up and walk test
Range of joint movement in the knee, degrees of movement measured with a protractor
Range of joint movement in the knee
Range of joint movement in the elbow, degrees of movement measured with a protractor
Range of joint movement in the elbow
Self perceived health
Perceived health assessed by questionnaire
Level of physical activity
Level of physical activity assessed by questionnaire

Full Information

First Posted
November 11, 2019
Last Updated
May 18, 2020
Sponsor
Inland Norway University of Applied Sciences
Collaborators
Montebellosenteret, Mesnali, Norway
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1. Study Identification

Unique Protocol Identification Number
NCT04196725
Brief Title
Effect of Lifestyle Intervention vs Physical Therapy Treatment in Patients With Secondary Lymphedema After Cancer
Official Title
Effect of Lifestyle Intervention vs Physical Therapy Treatment in Patients With Secondary Lymphedema After Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
December 6, 2019 (Actual)
Primary Completion Date
April 4, 2020 (Actual)
Study Completion Date
April 4, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Inland Norway University of Applied Sciences
Collaborators
Montebellosenteret, Mesnali, Norway

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphedema, Secondary

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Physical therapy treatment
Arm Type
Experimental
Arm Title
Lifestyle treatment
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Arm Description
Parallel control group, not undertaking any treatment and not part of the cross-over design
Intervention Type
Other
Intervention Name(s)
Physical therapy treatment
Intervention Description
Two weeks rehabilitation programme focusing on physical therapy treatment, e.g. manual lymphatic drainage and compression bandaging
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle treatment
Intervention Description
Two weeks rehabilitation programme focusing on physical activity
Primary Outcome Measure Information:
Title
Lymphedema
Description
Ratio of the volume of affected limb vs volume of nonaffected limb measured by DXA
Time Frame
Change from before to the end of each of the two week rehabilitation programmes.
Secondary Outcome Measure Information:
Title
Maximal strength
Description
In handgrip and knee-extension
Time Frame
Measured immediately before and at the end of each of the two week rehabilitation programmes.
Title
Balance
Description
One leg balance test
Time Frame
Measured immediately before and at the end of each of the two week rehabilitation programmes.
Title
Flexibility in hip and back
Description
Sit and reach test
Time Frame
Measured immediately before and at the end of each of the two week rehabilitation programmes.
Title
Flexibility in shoulder
Description
Back scratch test
Time Frame
Measured immediately before and at the end of each of the two week rehabilitation programmes.
Title
Test of physical functionality
Description
Stand up and walk test
Time Frame
Measured immediately before and at the end of each of the two week rehabilitation programmes.
Title
Range of joint movement in the knee, degrees of movement measured with a protractor
Description
Range of joint movement in the knee
Time Frame
Measured immediately before and at the end of each of the two week rehabilitation programmes.
Title
Range of joint movement in the elbow, degrees of movement measured with a protractor
Description
Range of joint movement in the elbow
Time Frame
Measured immediately before and at the end of each of the two week rehabilitation programmes.
Title
Self perceived health
Description
Perceived health assessed by questionnaire
Time Frame
Measured immediately before and at the end of each of the two week rehabilitation programmes.
Title
Level of physical activity
Description
Level of physical activity assessed by questionnaire
Time Frame
Questionnaire will be completed immediately before the rehabilitation programmes, assessing the level of physical activity the prior three months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Secondary lymphedema in arm or/and leg related to cancer Exclusion Criteria: -
Facility Information:
Facility Name
Inland Norway University of Applied Sciences
City
Lillehammer
Country
Norway

12. IPD Sharing Statement

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

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