Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04196725
Enrollment
28
Registered
2019-12-12
Start date
2019-12-06
Completion date
2020-04-04
Last updated
2020-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphedema, Secondary

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.

Interventions

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

Two weeks rehabilitation programme focusing on physical activity

Sponsors

Montebellosenteret, Mesnali, Norway
CollaboratorUNKNOWN
Inland Norway University of Applied Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
LymphedemaChange 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

MeasureTime frameDescription
BalanceMeasured immediately before and at the end of each of the two week rehabilitation programmes.One leg balance test
Flexibility in hip and backMeasured immediately before and at the end of each of the two week rehabilitation programmes.Sit and reach test
Flexibility in shoulderMeasured immediately before and at the end of each of the two week rehabilitation programmes.Back scratch test
Test of physical functionalityMeasured immediately before and at the end of each of the two week rehabilitation programmes.Stand up and walk test
Maximal strengthMeasured immediately before and at the end of each of the two week rehabilitation programmes.In handgrip and knee-extension
Range of joint movement in the elbow, degrees of movement measured with a protractorMeasured immediately before and at the end of each of the two week rehabilitation programmes.Range of joint movement in the elbow
Self perceived healthMeasured immediately before and at the end of each of the two week rehabilitation programmes.Perceived health assessed by questionnaire
Level of physical activityQuestionnaire 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
Range of joint movement in the knee, degrees of movement measured with a protractorMeasured immediately before and at the end of each of the two week rehabilitation programmes.Range of joint movement in the knee

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026