Physical Function and Activities of Daily Living in Cancer Patients During Chemotherapy
Primary Purpose
Advanced Gastrointestinal Cancer
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
home-based exercise intervention
Sponsored by
About this trial
This is an interventional supportive care trial for Advanced Gastrointestinal Cancer
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
Sites / Locations
- Agaplesion Markus Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
home-based exercise intervention
Waiting control group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Short Physical Performance Battery
Short battery of physical performance tests used to assess lower extremity function. Balance, gait, strength, and endurance are evaluated.
Secondary Outcome Measures
Daily physical activity
7 days accelerometry
Polyneuropathy
Measuring the sensibility with a Rydel-Seiffer tuning fork
Gait speed
usual gait speed (km/h) on a capacitive force-measuring platform (30Hz) WinFDM v0.0.41® (Zebris© GmbH, Isny, Germany)
Postural sway
balance measuring (COP) on a capacitive force-measuring platform (30Hz) WinFDM v0.0.41® (Zebris© GmbH, Isny, Germany)
Maximum isometric voluntary force of the upper extremity
JAMAR Hand Dynamometer
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°).
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.
Quality of life
European Organisation for Research and Treatment of Cancer (EORTC_QLQ-C30)
Quality of life
The 36-Items Short Form Health Survey (SF-36)
Nutrition Assessment
Mini Nutritional Assessment (MNA)
Phase angle
multifrequent bioelectrical impedance analysis (DATA-Input) measuring the phase angle
Body cell mass
multifrequent bioelectrical impedance analysis (DATA-Input) measuring the body cell mass (BCM)
Fat mass
multifrequent bioelectrical impedance analysis (DATA-Input) measuring the fat mass
Perceived functional ability
perceived functional ability scale
Activities of daily living
Functional Independence Measurement (FIM) Questionnaire
Activities of daily living
- instrumental Activity of Daily Living (iADL)
Full Information
NCT ID
NCT02677129
First Posted
February 2, 2016
Last Updated
April 11, 2017
Sponsor
Goethe University
Collaborators
Agaplesion Markus Krankenhaus gGmbH
1. Study Identification
Unique Protocol Identification Number
NCT02677129
Brief Title
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
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
August 2014 (Actual)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
November 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Goethe University
Collaborators
Agaplesion Markus Krankenhaus gGmbH
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Gastrointestinal Cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
home-based exercise intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Waiting control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
home-based exercise intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Short Physical Performance Battery
Description
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
Secondary Outcome Measure Information:
Title
Daily physical activity
Description
7 days accelerometry
Time Frame
3 times in the course of 12 weeks of chemotherapy
Title
Polyneuropathy
Description
Measuring the sensibility with a Rydel-Seiffer tuning fork
Time Frame
3 times in the course of 12 weeks of chemotherapy
Title
Gait speed
Description
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
Title
Postural sway
Description
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
Title
Maximum isometric voluntary force of the upper extremity
Description
JAMAR Hand Dynamometer
Time Frame
3 times in the course of 12 weeks of chemotherapy
Title
Maximum isometric voluntary force of the lower extremity
Description
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
Title
Muscular endurance (Chair-Rise Test)
Description
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
Title
Quality of life
Description
European Organisation for Research and Treatment of Cancer (EORTC_QLQ-C30)
Time Frame
3 times in the course of 12 weeks of chemotherapy
Title
Quality of life
Description
The 36-Items Short Form Health Survey (SF-36)
Time Frame
3 times in the course of 12 weeks of chemotherapy
Title
Nutrition Assessment
Description
Mini Nutritional Assessment (MNA)
Time Frame
3 times in the course of 12 weeks of chemotherapy
Title
Phase angle
Description
multifrequent bioelectrical impedance analysis (DATA-Input) measuring the phase angle
Time Frame
3 times in the course of 12 weeks of chemotherapy
Title
Body cell mass
Description
multifrequent bioelectrical impedance analysis (DATA-Input) measuring the body cell mass (BCM)
Time Frame
3 times in the course of 12 weeks of chemotherapy
Title
Fat mass
Description
multifrequent bioelectrical impedance analysis (DATA-Input) measuring the fat mass
Time Frame
3 times in the course of 12 weeks of chemotherapy
Title
Perceived functional ability
Description
perceived functional ability scale
Time Frame
3 times in the course of 12 weeks of chemotherapy
Title
Activities of daily living
Description
Functional Independence Measurement (FIM) Questionnaire
Time Frame
Change between the first 12 weeks of chemotherapy
Title
Activities of daily living
Description
- instrumental Activity of Daily Living (iADL)
Time Frame
Change between the first 12 weeks of chemotherapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Winfried Banzer, Prof.
Organizational Affiliation
Department of Sports Medicine, Goethe University Frankfurt
Official's Role
Principal Investigator
Facility Information:
Facility Name
Agaplesion Markus Hospital
City
Frankfurt
ZIP/Postal Code
60487
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Only pseudonymised data without the plan to share
Learn more about this trial
Physical Function and Activities of Daily Living in Cancer Patients During Chemotherapy
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