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Completed

NCT Number: NCT02677129

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

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Key information

Conditions

Advanced Gastrointestinal Cancer

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Agaplesion Markus Hospital

Frankfurt, 60487, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Home-based exercise intervention

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Daily physical activity

    Time frame: 3 times in the course of 12 weeks of chemotherapy

    7 days accelerometry

  2. Polyneuropathy

    Time frame: 3 times in the course of 12 weeks of chemotherapy

    Measuring the sensibility with a Rydel-Seiffer tuning fork

  3. 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)

  4. 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)

  5. Maximum isometric voluntary force of the upper extremity

    Time frame: 3 times in the course of 12 weeks of chemotherapy

    JAMAR Hand Dynamometer

  6. 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°).

  7. 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.

  8. 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)

  9. Quality of life

    Time frame: 3 times in the course of 12 weeks of chemotherapy

    The 36-Items Short Form Health Survey (SF-36)

  10. Nutrition Assessment

    Time frame: 3 times in the course of 12 weeks of chemotherapy

    Mini Nutritional Assessment (MNA)

  11. Phase angle

    Time frame: 3 times in the course of 12 weeks of chemotherapy

    multifrequent bioelectrical impedance analysis (DATA-Input) measuring the phase angle

  12. 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)

  13. Fat mass

    Time frame: 3 times in the course of 12 weeks of chemotherapy

    multifrequent bioelectrical impedance analysis (DATA-Input) measuring the fat mass

  14. Perceived functional ability

    Time frame: 3 times in the course of 12 weeks of chemotherapy

    perceived functional ability scale

  15. Activities of daily living

    Time frame: Change between the first 12 weeks of chemotherapy

    Functional Independence Measurement (FIM) Questionnaire

  16. Activities of daily living

    Time frame: Change between the first 12 weeks of chemotherapy

    • instrumental Activity of Daily Living (iADL)

Sponsors and collaborators

Lead sponsor

Goethe University

Other

Collaborators

  • Agaplesion Markus Krankenhaus gGmbH

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Feb 9, 2016
Registry last updated
Apr 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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