Clinical trial NCT04196725: 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
Overall status: COMPLETED
Phase: NA
Conditions: Lymphedema, Secondary
Lead sponsor: Inland Norway University of Applied Sciences
Sponsor class: OTHER
Collaborators: name: Montebellosenteret, Mesnali, Norway
First posted: 2019-12-12
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

-

Primary outcomes:
measure: Lymphedema
timeFrame: Change from before to the end of each of the two week rehabilitation programmes.
Secondary outcomes:
measure: Maximal strength
timeFrame: Measured immediately before and at the end of each of the two week rehabilitation programmes.
measure: Balance
timeFrame: Measured immediately before and at the end of each of the two week rehabilitation programmes.
measure: Flexibility in hip and back
timeFrame: Measured immediately before and at the end of each of the two week rehabilitation programmes.
measure: Flexibility in shoulder
timeFrame: Measured immediately before and at the end of each of the two week rehabilitation programmes.
measure: Test of physical functionality
timeFrame: Measured immediately before and at the end of each of the two week rehabilitation programmes.
measure: Range of joint movement in the knee, degrees of movement measured with a protractor
timeFrame: Measured immediately before and at the end of each of the two week rehabilitation programmes.
measure: Range of joint movement in the elbow, degrees of movement measured with a protractor
timeFrame: Measured immediately before and at the end of each of the two week rehabilitation programmes.
measure: Self perceived health
timeFrame: Measured immediately before and at the end of each of the two week rehabilitation programmes.
measure: Level of physical activity
timeFrame: Questionnaire will be completed immediately before the rehabilitation programmes, assessing the level of physical activity the prior three months.
Other outcomes:
Locations:
city: Lillehammer
country: Norway
facility: Inland Norway University of Applied Sciences
Study officials:
References: