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

I

Inland Norway University of Applied Sciences

Status

Completed

Conditions

Lymphedema, Secondary

Treatments

Other: Physical therapy treatment
Behavioral: Lifestyle treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT04196725
Montebello19

Details and patient eligibility

About

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.

Full 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.

Enrollment

28 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

28 participants in 3 patient groups

Physical therapy treatment
Experimental group
Treatment:
Other: Physical therapy treatment
Lifestyle treatment
Experimental group
Treatment:
Behavioral: Lifestyle treatment
Control
No Intervention group
Description:
Parallel control group, not undertaking any treatment and not part of the cross-over design

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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