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CompletedNCT04151238Updated Nov 2, 2022

Exercise Intervention for Cancer Patients

An interventional study of Exercise intervention for cancer patients to increase physical activity during chemotherapy in Cancer, sponsored by Turku University Hospital. Completed at 1 site in Finland. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-11-02.

Sponsored by Turku University Hospital · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
8
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study summary

Exhausting chemotherapy, adverse effects of chemotherapy and a lack of information on the benefits of physical exercise are the among the reasons for reduced physical exercise among cancer patients during chemotherapy courses. According to best current knowledge only about 10% of cancer patients in Finland are physically active during cancer treatment. In addition, only 20-30% are physically active after recovery from the treatments (Pylkkänen, 2015). There is only little awareness about the benefits of physical activity during cancer treatments. The purpose of the exercise intervention study is to increase the physical activity of patients who are on chemotherapy.

The study is a pilot trial and has no control group. Internationally, exercise interventions have been studied among cancer patients on treatment for decades. The American College of Sports Medicine (ACSM) recommends that cancer patients should have 150 minutes of endurance exercise per week and at least two bouts of muscle strength exercise per week. Consequently, the exercise intervention study will have a combination of muscle power and endurance training. To reach the weekly recommended level of exercise, the cancer patients in the study will additionally have a weekly home training program containing preferentially endurance training. A literature search shows that no studies on exercise interventions during cancer treatment have been published in Finland. Thus, this thesis carries the wider implication of increasing the general knowledge on the importance of physical activity of cancer patients.

Read the detailed description

The duration of the exercise intervention is eight (8) weeks. There will be guided endurance and muscle power training two (2) time weekly. The participants will also be provided with one training program per week for use at home. Data on training at home and other items of physical activity is recorded in a diary. Before the intervention is started, an oncologist will examine the participants condition before brisk physical activity is started. Safety is an important consideration and a nurse will examine the patients before each bout of exercise. A nurse will be present during the entire time of the exercise. A physician is always available for consultations by phone.

Before the intervention starts, baseline measurements will be made in the laboratories of physical exercise in the Tyks Hospital and the Turku University of Applied Sciences. At baseline, endurance, muscle power, balance and body composition will be evaluated and recorded. Endurance will be measured with a submaximal treadmill test. Muscle power will be assessed by a dynamic elevation test, hand pressure test, the lower extremities by repeated squatting-standing and by rising to stand on the toes. Balance is measured in the specific sway platform (one leg and both legs standing). The patients will be asked to fill questionnaires on quality of life (QLQ-c30) and fatigue (FACIT-F) before and after the intervention. The patients will fill in their exercise diaries from the very moment their participation has been decided until the end of the intervention. After exercise intervention the patients also fill the feedback-questionnaire.

02

Conditions studied

  • Cancer
03

In context

Lead sponsor

Turku University Hospital is the lead sponsor of 280 studies on the registry; 65 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • cancer patients in the age of 18-70
  • in the early phase of chemotherapy
  • first line chemotherapy
  • active way of treating cancer
  • solid tumor (breast cancer, prostata cancer, colon cancer and melanoma)
  • Finnish-speaking
  • z=0-1 (no aids)
  • capable travelling to University hospital for 8 weeks twice a week
  • normal or poor physical activity background

Exclusion criteria

Exclusion Criteria:

  • exercise contraindications, like severe respiratory or circulatory system disease (eg. heart attack \<3)
  • brain or bone metastasis
  • heterogenous group (max 4 patients per cancer diagnose)
  • thrombocytopenia
  • leukocytopenia
  • immuno-oncological treatments
  • really "athlete patients"
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
8 participants (actual)

Study arms

  • Experimental
    Exercise intervention

    The duration of the exercise intervention is eight (8) weeks. There will be guided endurance and muscle power training two (2) time weekly. The participants will also be provided with one training program per week for use at home. Data on training at home and other items of physical activity is recorded in a diary.

    Behavioral: Exercise intervention for cancer patients to increase physical activity during chemotherapy

Interventions

  • BehavioralExercise intervention for cancer patients to increase physical activity during chemotherapy

    The duration of the exercise intervention is eight (8) weeks. There will be guided endurance and muscle power training two (2) time weekly. The participants will also be provided with one training program per week for use at home.

06

What researchers measure

Primary outcomes

  1. physical activity changes in diary

    Does this exercise intervention model works for cancer patients to increase the amount of physical activity and to achieve the cancer patients exercise recommendations? (especially home-exercising)

    Time frame: 0 and 8 weeks,

  2. questionnaire-feedback from cancer patients

    Does this exercise intervention model works for cancer patients to change the amount of physical activity? Patients subjective feedback about the first exercise group model in special health care. The questions are formed in quantitative way.

    Time frame: 0 and 8 weeks

Secondary outcomes

  1. Quality of life questionnaire (EORTC QLQ-c30)

    Does the guided exercise intervention (physical activity) affect the patients quality of life during chemotherapy? The scales and single-item measures range in score from 0 to 100. High score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems. The scale consists of three different part.

    Time frame: 0 and 8 weeks

  2. Fatigue questionnaire (FACIT-F)

    Does the guided exercise intervention (physical activity) affect the patients fatigue during chemotherapy? The score range: 0-52 points. The bigger points the worse fatigue or more symptoms.

    Time frame: 0 and 8 weeks

  3. Body composition in cancer patients general view (In-Body-device)

    Does exercise intervention (physical activity) cause changes in the body composition of cancer patients on chemotherapy? The device measures body mass index, fluid, fat and muscle changes. We follow up the changes in general view.

    Time frame: 0 and 8 weeks

  4. Endurance (submaximal treadmill test)

    Does exercise intervention (physical activity) cause changes in endurance of cancer patients on chemotherapy?

    Time frame: 0 and 8 weeks

  5. Functional muscle power test - dynamic elevation test for upper arms

    Does exercise intervention (physical activity) cause changes in muscle power of cancer patients on chemotherapy?

    Time frame: 0 and 8 weeks

  6. Functional muscle power test - hand pressure test

    Does exercise intervention (physical activity) cause changes in muscle power of cancer patients on chemotherapy?

    Time frame: 0 and 8 weeks

  7. Functional muscle power test - the lower extremities by repeated squatting-standing

    Does exercise intervention (physical activity) cause changes in muscle power of cancer patients on chemotherapy?

    Time frame: 0 and 8 weeks

  8. Functional muscle power test - the lower extremities by rising to stand on the toes

    Does exercise intervention (physical activity) cause changes in muscle power of cancer patients on chemotherapy?

    Time frame: 0 and 8 weeks

  9. Functional muscle power test - plank-test for the body

    Does exercise intervention (physical activity) cause changes in muscle power of cancer patients on chemotherapy?

    Time frame: 0 and 8 weeks

  10. Balance -tests in specific sway-platform (standing with both legs and only one leg in sway-platform)

    Does exercise intervention (physical activity) cause changes in the balance of cancer patients on chemotherapy?

    Time frame: 0 and 8 weeks

07

Study locations

1 site
  • Turku University hospital
    Turku, 20521, Finland
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 2, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04151238
Lead sponsor
Turku University Hospital
Collaborators
Turku AMK Master School
Responsible party
Sponsor
First posted
Nov 5, 2019
Start date
Feb 17, 2020
Primary completion
Apr 16, 2020
Completion
May 8, 2020
Last update
Nov 2, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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