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

Lymphedema, Secondary Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04196725
• Other study ID #: Montebello19
• Status: Completed
• Phase: N/A
• Start date: December 6, 2019
• Est. completion date: April 4, 2020

Study information

• Verified date: December 2019
• Source: Inland Norway University of Applied Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: April 4, 2020
• Est. primary completion date: April 4, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Lymphedema
• Lymphedema, Secondary
• Neoplasm Metastasis

Intervention

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

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

Locations

Country	Name	City	State
Norway	Inland Norway University of Applied Sciences	Lillehammer

Sponsors (2)

Lead Sponsor	Collaborator
Inland Norway University of Applied Sciences	Montebellosenteret, Mesnali, Norway

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Maximal strength	In handgrip and knee-extension	Measured immediately before and at the end of each of the two week rehabilitation programmes.
Secondary	Balance	One leg balance test	Measured immediately before and at the end of each of the two week rehabilitation programmes.
Secondary	Flexibility in hip and back	Sit and reach test	Measured immediately before and at the end of each of the two week rehabilitation programmes.
Secondary	Flexibility in shoulder	Back scratch test	Measured immediately before and at the end of each of the two week rehabilitation programmes.
Secondary	Test of physical functionality	Stand up and walk test	Measured immediately before and at the end of each of the two week rehabilitation programmes.
Secondary	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.
Secondary	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.
Secondary	Self perceived health	Perceived health assessed by questionnaire	Measured immediately before and at the end of each of the two week rehabilitation programmes.
Secondary	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.