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

Goethe University

Status: Completed

Conditions: Advanced Gastrointestinal Cancer

Treatments: Other: home-based exercise intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT02677129

SPM2015-003

Details and patient eligibility

About

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

Full 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.

Enrollment: 44 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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44 participants in 2 patient groups

home-based exercise intervention

Experimental group

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.

Treatment:

Other: home-based exercise intervention

Waiting control group

No Intervention group

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.