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

Study Overview
=================
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.

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

Conditions
-----------------
Advanced Gastrointestinal Cancer

Intervention / Treatment
-----------------
* Other: home-based exercise intervention


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: home-based exercise intervention<br>home-based exercise intervention: Endurance 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. | Other: home-based exercise intervention<br>* Endurance 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.<br>|
| No Intervention: Waiting control group<br>The wait list control group receives usual care over the study period. Usual care depends on the hospital guidelines as well as oncologists' and physicians' consideration. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short Physical Performance Battery | Short battery of physical performance tests used to assess lower extremity function. Balance, gait, strength, and endurance are evaluated. | Change between the first 12 weeks of chemotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily physical activity | 7 days accelerometry | 3 times in the course of 12 weeks of chemotherapy | 
| Polyneuropathy | Measuring the sensibility with a Rydel-Seiffer tuning fork | 3 times in the course of 12 weeks of chemotherapy | 
| Gait speed | usual gait speed (km/h) on a capacitive force-measuring platform (30Hz) WinFDM v0.0.41® (Zebris© GmbH, Isny, Germany) | 3 times in the course of 12 weeks of chemotherapy | 
| Postural sway | balance measuring (COP) on a capacitive force-measuring platform (30Hz) WinFDM v0.0.41® (Zebris© GmbH, Isny, Germany) | 3 times in the course of 12 weeks of chemotherapy | 
| Maximum isometric voluntary force of the upper extremity | JAMAR Hand Dynamometer | 3 times in the course of 12 weeks of chemotherapy | 
| Maximum isometric voluntary force of the lower extremity | The maximal isometric voluntary force (MIVF) of the randomly chosen knee extensor is measured with a strain gauge force transducer (ASYS®; SPOREG; 100 Hz) in a standardised seating position (predefined knee and hip angle = 90°). | 3 times in the course of 12 weeks of chemotherapy | 
| Muscular endurance (Chair-Rise Test) | For the five times sit to stand test patients start in a standard position sitting on a chair that is placed next to the wall with the arms folded across their chest. They are asked to stand up from a chair to a full standing position and sit down again keeping the arms crossed for five times as quickly as possible. | 3 times in the course of 12 weeks of chemotherapy | 
| Quality of life | European Organisation for Research and Treatment of Cancer (EORTC_QLQ-C30) | 3 times in the course of 12 weeks of chemotherapy | 
| Quality of life | The 36-Items Short Form Health Survey (SF-36) | 3 times in the course of 12 weeks of chemotherapy | 
| Nutrition Assessment | Mini Nutritional Assessment (MNA) | 3 times in the course of 12 weeks of chemotherapy | 
| Phase angle | multifrequent bioelectrical impedance analysis (DATA-Input) measuring the phase angle | 3 times in the course of 12 weeks of chemotherapy | 
| Body cell mass | multifrequent bioelectrical impedance analysis (DATA-Input) measuring the body cell mass (BCM) | 3 times in the course of 12 weeks of chemotherapy | 
| Fat mass | multifrequent bioelectrical impedance analysis (DATA-Input) measuring the fat mass | 3 times in the course of 12 weeks of chemotherapy | 
| Perceived functional ability | perceived functional ability scale | 3 times in the course of 12 weeks of chemotherapy | 
| Activities of daily living | Functional Independence Measurement (FIM) Questionnaire | Change between the first 12 weeks of chemotherapy | 
| Activities of daily living | - instrumental Activity of Daily Living (iADL) | Change between the first 12 weeks of chemotherapy |