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

April 11, 2017 updated by: Prof. Dr. Dr. Winfried Banzer, Goethe University
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
44

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Short Physical Performance Battery
Time Frame: Change between the first 12 weeks of chemotherapy
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Daily physical activity
Time Frame: 3 times in the course of 12 weeks of chemotherapy
7 days accelerometry
3 times in the course of 12 weeks of chemotherapy
Polyneuropathy
Time Frame: 3 times in the course of 12 weeks of chemotherapy
Measuring the sensibility with a Rydel-Seiffer tuning fork
3 times in the course of 12 weeks of chemotherapy
Gait speed
Time Frame: 3 times in the course of 12 weeks of chemotherapy
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
Time Frame: 3 times in the course of 12 weeks of chemotherapy
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
Time Frame: 3 times in the course of 12 weeks of chemotherapy
JAMAR Hand Dynamometer
3 times in the course of 12 weeks of chemotherapy
Maximum isometric voluntary force of the lower extremity
Time Frame: 3 times in the course of 12 weeks of chemotherapy
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)
Time Frame: 3 times in the course of 12 weeks of chemotherapy
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
Time Frame: 3 times in the course of 12 weeks of chemotherapy
European Organisation for Research and Treatment of Cancer (EORTC_QLQ-C30)
3 times in the course of 12 weeks of chemotherapy
Quality of life
Time Frame: 3 times in the course of 12 weeks of chemotherapy
The 36-Items Short Form Health Survey (SF-36)
3 times in the course of 12 weeks of chemotherapy
Nutrition Assessment
Time Frame: 3 times in the course of 12 weeks of chemotherapy
Mini Nutritional Assessment (MNA)
3 times in the course of 12 weeks of chemotherapy
Phase angle
Time Frame: 3 times in the course of 12 weeks of chemotherapy
multifrequent bioelectrical impedance analysis (DATA-Input) measuring the phase angle
3 times in the course of 12 weeks of chemotherapy
Body cell mass
Time Frame: 3 times in the course of 12 weeks of chemotherapy
multifrequent bioelectrical impedance analysis (DATA-Input) measuring the body cell mass (BCM)
3 times in the course of 12 weeks of chemotherapy
Fat mass
Time Frame: 3 times in the course of 12 weeks of chemotherapy
multifrequent bioelectrical impedance analysis (DATA-Input) measuring the fat mass
3 times in the course of 12 weeks of chemotherapy
Perceived functional ability
Time Frame: 3 times in the course of 12 weeks of chemotherapy
perceived functional ability scale
3 times in the course of 12 weeks of chemotherapy
Activities of daily living
Time Frame: Change between the first 12 weeks of chemotherapy
Functional Independence Measurement (FIM) Questionnaire
Change between the first 12 weeks of chemotherapy
Activities of daily living
Time Frame: Change between the first 12 weeks of chemotherapy
- instrumental Activity of Daily Living (iADL)
Change between the first 12 weeks of chemotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Goethe University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Agaplesion Markus Krankenhaus gGmbH

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Winfried Banzer, Prof., Department of Sports Medicine, Goethe University Frankfurt

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 2, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 4, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 9, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 12, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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