Clinical Trials Directory

Trials / Completed

CompletedNCT02677129

Physical Function and Activities of Daily Living in Cancer Patients During Chemotherapy

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
44 (actual)
Sponsor
Goethe University · Academic / Other
Sex
All
Age
50 Years
Healthy volunteers
Not accepted

Summary

The study is a randomized controlled trial with the aim to examine the feasibility and the effects of a home-based exercise intervention program on activities of daily living (ADL) in patients with advanced gastrointestinal cancer undergoing chemotherapeutic treatment. Further outcomes include functional and body status, quality of life, body composition, and chemotherapy completion rate. Study participants will be randomized to an exercise intervention group or a wait-list control group

Detailed description

A randomised longitudinal study. A total of 44 gastrointestinal cancer patients before their first-line chemotherapy are recruited and randomised into one of two treatment groups A: Home based- physical activity or B: wait-control. The intervention period is 12 weeks. Primary outcome are the ADLs (iADL 1-8; FIM 1-7).Secondary outcomes are the physical activity, quality of life, peripheral polyneuropathy, chemotherapy regimen, gait speed, postural stability, maximal isometric voluntary force of the upper extremity, Maximal isometric voluntary force (MIVF) and strength endurance of the lower extremity, nutritional state, body composition and perceive functional ability. All measurements are standardized and are performed before chemotherapy, after 2 cycles of chemotherapy (4-6weeks) and after 12 weeks.

Conditions

Interventions

TypeNameDescription
OTHERhome-based exercise interventionEndurance training (moderate intensity; walking), 3-5 times per week Patients will receive exercise counselling how to realize the planned intervention home-based. Further, they will be asked to fill out an exercise log. The study team will periodically review adherence to the intervention and identify problems.

Timeline

Start date
2014-08-01
Primary completion
2016-09-01
Completion
2016-11-01
First posted
2016-02-09
Last updated
2017-04-12

Locations

1 site across 1 country: Germany

Source: ClinicalTrials.gov record NCT02677129. Inclusion in this directory is not an endorsement.