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Clinical Trials/NCT04151238
NCT04151238
Completed
Not Applicable

Exercise Intervention for Cancer Patients to Increase Physical Activity During Chemotherapy

Turku University Hospital1 site in 1 country8 target enrollmentFebruary 17, 2020
ConditionsCancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cancer
Sponsor
Turku University Hospital
Enrollment
8
Locations
1
Primary Endpoint
physical activity changes in diary
Status
Completed
Last Updated
3 years ago

Overview

Brief 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.

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.

Registry
clinicaltrials.gov
Start Date
February 17, 2020
End Date
May 8, 2020
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

  • 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"

Outcomes

Primary Outcomes

physical activity changes in diary

Time Frame: 0 and 8 weeks,

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)

questionnaire-feedback from cancer patients

Time Frame: 0 and 8 weeks

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.

Secondary Outcomes

  • Quality of life questionnaire (EORTC QLQ-c30)(0 and 8 weeks)
  • Functional muscle power test - hand pressure test(0 and 8 weeks)
  • Balance -tests in specific sway-platform (standing with both legs and only one leg in sway-platform)(0 and 8 weeks)
  • Endurance (submaximal treadmill test)(0 and 8 weeks)
  • Functional muscle power test - dynamic elevation test for upper arms(0 and 8 weeks)
  • Body composition in cancer patients general view (In-Body-device)(0 and 8 weeks)
  • Functional muscle power test - the lower extremities by repeated squatting-standing(0 and 8 weeks)
  • Functional muscle power test - the lower extremities by rising to stand on the toes(0 and 8 weeks)
  • Fatigue questionnaire (FACIT-F)(0 and 8 weeks)
  • Functional muscle power test - plank-test for the body(0 and 8 weeks)

Study Sites (1)

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