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

NCT04196725 | Completed

• 1 other identifier: Montebello19
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphedema, Secondary

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Maximal strength

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

• Balance

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

• Flexibility in hip and back

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

• Flexibility in shoulder

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

• Test of physical functionality

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

Study Arms (3)

Physical therapy treatment

EXPERIMENTAL

Other: Physical therapy treatment

Lifestyle treatment

EXPERIMENTAL

Behavioral: Lifestyle treatment

Control

NO INTERVENTION

Parallel control group, not undertaking any treatment and not part of the cross-over design

Interventions

Physical therapy treatment OTHER

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

Physical therapy treatment

Lifestyle treatment BEHAVIORAL

Two weeks rehabilitation programme focusing on physical activity

Lifestyle treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Inland Norway University of Applied Sciences: lead
• Montebellosenteret, Mesnali, Norway: collaborator

Study Sites (1)

Inland Norway University of Applied Sciences

Lillehammer, Norway

Location

MeSH Terms

Conditions

Lymphedema; Neoplasm Metastasis

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 11, 2019
• First Posted: December 12, 2019
• Study Start: December 6, 2019
• Primary Completion: April 4, 2020
• Study Completion: April 4, 2020
• Last Updated: May 20, 2020

Record last verified: 2019-12

Locations

NO (1)