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Completed

NCT Number: NCT04196725

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

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.

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Key information

Conditions

Lymphedema, Secondary Hemic and Lymphatic Diseases Lymphatic Diseases Lymphedema Neoplasm Metastasis Neoplasms Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Inland Norway University of Applied Sciences

Lillehammer, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-

Treatment and study plan

physical therapy treatment

Other

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

Lifestyle treatment

Behavioral

Two weeks rehabilitation programme focusing on physical activity

Primary outcomes

  1. Lymphedema

    Time frame: 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 outcomes

  1. Maximal strength

    Time frame: Measured immediately before and at the end of each of the two week rehabilitation programmes.

    In handgrip and knee-extension

  2. Balance

    Time frame: 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

    Time frame: Measured immediately before and at the end of each of the two week rehabilitation programmes.

    Sit and reach test

  4. Flexibility in shoulder

    Time frame: Measured immediately before and at the end of each of the two week rehabilitation programmes.

    Back scratch test

  5. Test of physical functionality

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Inland Norway University of Applied Sciences

Other

Collaborators

  • Montebellosenteret, Mesnali, Norway

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 12, 2019
Registry last updated
May 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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