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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
44
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.
Agaplesion Markus Hospital
Frankfurt, Germany
Short Physical Performance Battery
Short battery of physical performance tests used to assess lower extremity function. Balance, gait, strength, and endurance are evaluated.
Time frame: Change between the first 12 weeks of chemotherapy
Daily physical activity
7 days accelerometry
Time frame: 3 times in the course of 12 weeks of chemotherapy
Polyneuropathy
Measuring the sensibility with a Rydel-Seiffer tuning fork
Time frame: 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)
Time frame: 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)
Time frame: 3 times in the course of 12 weeks of chemotherapy
Maximum isometric voluntary force of the upper extremity
JAMAR Hand Dynamometer
Time frame: 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°).
Time frame: 3 times in the course of 12 weeks of chemotherapy
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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.
Time frame: 3 times in the course of 12 weeks of chemotherapy
Quality of life
European Organisation for Research and Treatment of Cancer (EORTC\_QLQ-C30)
Time frame: 3 times in the course of 12 weeks of chemotherapy
Quality of life
The 36-Items Short Form Health Survey (SF-36)
Time frame: 3 times in the course of 12 weeks of chemotherapy
Nutrition Assessment
Mini Nutritional Assessment (MNA)
Time frame: 3 times in the course of 12 weeks of chemotherapy
Phase angle
multifrequent bioelectrical impedance analysis (DATA-Input) measuring the phase angle
Time frame: 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)
Time frame: 3 times in the course of 12 weeks of chemotherapy
Fat mass
multifrequent bioelectrical impedance analysis (DATA-Input) measuring the fat mass
Time frame: 3 times in the course of 12 weeks of chemotherapy
Perceived functional ability
perceived functional ability scale
Time frame: 3 times in the course of 12 weeks of chemotherapy
Activities of daily living
Functional Independence Measurement (FIM) Questionnaire
Time frame: Change between the first 12 weeks of chemotherapy
Activities of daily living
\- instrumental Activity of Daily Living (iADL)
Time frame: Change between the first 12 weeks of chemotherapy