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

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

Study Overview

• Status: Completed
• Conditions: Advanced Gastrointestinal Cancer
• Intervention / Treatment: Other: home-based exercise intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Frankfurt, Germany, 60487
    • Agaplesion Markus Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: home-based exercise intervention; 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; 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.
No Intervention: Waiting control group; 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

Collaborators and Investigators

• Sponsor: Goethe University
• Collaborators: Agaplesion Markus Krankenhaus gGmbH
• Investigators: Principal Investigator: Winfried Banzer, Prof., Department of Sports Medicine, Goethe University Frankfurt

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2014
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: February 2, 2016
• First Submitted That Met QC Criteria: February 4, 2016
• First Posted (Estimate): February 9, 2016

Study Record Updates

• Last Update Posted (Actual): April 12, 2017
• Last Update Submitted That Met QC Criteria: April 11, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Gastrointestinal Diseases; Gastrointestinal Neoplasms
• Other Study ID Numbers: SPM2015-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Only pseudonymised data without the plan to share