Clinical trial NCT02677129: Physical Function and Activities of Daily Living in Cancer Patients During Chemotherapy
Official title: Physical Function and Activities of Daily Living in Cancer Patients During Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Advanced Gastrointestinal Cancer
Lead sponsor: Goethe University
Sponsor class: OTHER
Collaborators: name: Agaplesion Markus Krankenhaus gGmbH
First posted: 2016-02-09
Enrollment: 44
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Histologically classified gastrointestinal cancer
* UICC III-IV
* Prior to (planned) first-line chemotherapy (curative und palliative)
* ≥50 years

Exclusion Criteria:

* ECOG \> 2
* Systemic diseases (MS, ALS)
* disorders (neurological, skeletal, muscular, mental or cognitive) or drug use (irrespective of the cancer therapy) that may affect gait, balance or muscular strength
* chronic infection, uncontrolled hypertension (diastolic pressure over 95 mmHg)
* vestibulopathies
* uncorrected visual deficits

Primary outcomes:
measure: Short Physical Performance Battery
timeFrame: Change between the first 12 weeks of chemotherapy
Secondary outcomes:
measure: Daily physical activity
timeFrame: 3 times in the course of 12 weeks of chemotherapy
measure: Polyneuropathy
timeFrame: 3 times in the course of 12 weeks of chemotherapy
measure: Gait speed
timeFrame: 3 times in the course of 12 weeks of chemotherapy
measure: Postural sway
timeFrame: 3 times in the course of 12 weeks of chemotherapy
measure: Maximum isometric voluntary force of the upper extremity
timeFrame: 3 times in the course of 12 weeks of chemotherapy
measure: Maximum isometric voluntary force of the lower extremity
timeFrame: 3 times in the course of 12 weeks of chemotherapy
measure: Muscular endurance (Chair-Rise Test)
timeFrame: 3 times in the course of 12 weeks of chemotherapy
measure: Quality of life
timeFrame: 3 times in the course of 12 weeks of chemotherapy
measure: Quality of life
timeFrame: 3 times in the course of 12 weeks of chemotherapy
measure: Nutrition Assessment
timeFrame: 3 times in the course of 12 weeks of chemotherapy
measure: Phase angle
timeFrame: 3 times in the course of 12 weeks of chemotherapy
measure: Body cell mass
timeFrame: 3 times in the course of 12 weeks of chemotherapy
measure: Fat mass
timeFrame: 3 times in the course of 12 weeks of chemotherapy
measure: Perceived functional ability
timeFrame: 3 times in the course of 12 weeks of chemotherapy
measure: Activities of daily living
timeFrame: Change between the first 12 weeks of chemotherapy
measure: Activities of daily living
timeFrame: Change between the first 12 weeks of chemotherapy
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: Agaplesion Markus Hospital
Study officials:
affiliation: Department of Sports Medicine, Goethe University Frankfurt
name: Winfried Banzer, Prof.
role: PRINCIPAL_INVESTIGATOR
References: