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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2016-11-30

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Advanced Gastrointestinal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

home-based exercise intervention

Intervention Type OTHER

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No