Clinical trial NCT04151238: Exercise Intervention for Cancer Patients
Official title: Exercise Intervention for Cancer Patients to Increase Physical Activity During Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Turku AMK Master School
First posted: 2019-11-05
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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"

Primary outcomes:
measure: physical activity changes in diary
timeFrame: 0 and 8 weeks,
measure: questionnaire-feedback from cancer patients
timeFrame: 0 and 8 weeks
Secondary outcomes:
measure: Quality of life questionnaire (EORTC QLQ-c30)
timeFrame: 0 and 8 weeks
measure: Fatigue questionnaire (FACIT-F)
timeFrame: 0 and 8 weeks
measure: Body composition in cancer patients general view (In-Body-device)
timeFrame: 0 and 8 weeks
measure: Endurance (submaximal treadmill test)
timeFrame: 0 and 8 weeks
measure: Functional muscle power test - dynamic elevation test for upper arms
timeFrame: 0 and 8 weeks
measure: Functional muscle power test - hand pressure test
timeFrame: 0 and 8 weeks
measure: Functional muscle power test - the lower extremities by repeated squatting-standing
timeFrame: 0 and 8 weeks
measure: Functional muscle power test - the lower extremities by rising to stand on the toes
timeFrame: 0 and 8 weeks
measure: Functional muscle power test - plank-test for the body
timeFrame: 0 and 8 weeks
measure: Balance -tests in specific sway-platform (standing with both legs and only one leg in sway-platform)
timeFrame: 0 and 8 weeks
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Turku University hospital
Study officials:
References: