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

Sponsor
Inland Norway University of Applied Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT04196725
Collaborator
Montebellosenteret, Mesnali, Norway (Other)
28
1
3
3.9
7.1

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Physical therapy treatment
  • Behavioral: Lifestyle treatment
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
28 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention 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.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 (Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effect of Lifestyle Intervention vs Physical Therapy Treatment in Patients With Secondary Lymphedema After Cancer
Actual Study Start Date :
Dec 6, 2019
Actual Primary Completion Date :
Apr 4, 2020
Actual Study Completion Date :
Apr 4, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Physical therapy treatment

Other: Physical therapy treatment
Two weeks rehabilitation programme focusing on physical therapy treatment, e.g. manual lymphatic drainage and compression bandaging

Experimental: Lifestyle treatment

Behavioral: Lifestyle treatment
Two weeks rehabilitation programme focusing on physical activity

No Intervention: Control

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Maximal strength [Measured immediately before and at the end of each of the two week rehabilitation programmes.]

    In handgrip and knee-extension

  2. Balance [Measured immediately before and at the end of each of the two week rehabilitation programmes.]

    One leg balance test

  3. Flexibility in hip and back [Measured immediately before and at the end of each of the two week rehabilitation programmes.]

    Sit and reach test

  4. Flexibility in shoulder [Measured immediately before and at the end of each of the two week rehabilitation programmes.]

    Back scratch test

  5. Test of physical functionality [Measured immediately before and at the end of each of the two week rehabilitation programmes.]

    Stand up and walk test

  6. 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

  7. 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

  8. Self perceived health [Measured immediately before and at the end of each of the two week rehabilitation programmes.]

    Perceived health assessed by questionnaire

  9. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Secondary lymphedema in arm or/and leg related to cancer
Exclusion Criteria:

Contacts and Locations

Locations

Site City State Country Postal Code
1 Inland Norway University of Applied Sciences Lillehammer Norway

Sponsors and Collaborators

  • Inland Norway University of Applied Sciences
  • Montebellosenteret, Mesnali, Norway

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Inland Norway University of Applied Sciences
ClinicalTrials.gov Identifier:
NCT04196725
Other Study ID Numbers:
  • Montebello19
First Posted:
Dec 12, 2019
Last Update Posted:
May 20, 2020
Last Verified:
Dec 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 20, 2020