Exercise Intervention for Cancer Patients

Cancer Clinical Trial

Official title:

Exercise Intervention for Cancer Patients to Increase Physical Activity During Chemotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04151238
• Other study ID #: T306/2019
• Status: Completed
• Phase: N/A
• Start date: February 17, 2020
• Est. completion date: May 8, 2020

Study information

• Verified date: November 2022
• Source: Turku University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: May 8, 2020
• Est. primary completion date: April 16, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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"

Related Conditions & MeSH terms

• Cancer

Intervention

Behavioral:
• Exercise 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.

Locations

Country	Name	City	State
Finland	Turku University hospital	Turku

Sponsors (2)

Lead Sponsor	Collaborator
Turku University Hospital	Turku AMK Master School

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	0 and 8 weeks,
Primary	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.	0 and 8 weeks
Secondary	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.	0 and 8 weeks
Secondary	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.	0 and 8 weeks
Secondary	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.	0 and 8 weeks
Secondary	Endurance (submaximal treadmill test)	Does exercise intervention (physical activity) cause changes in endurance of cancer patients on chemotherapy?	0 and 8 weeks
Secondary	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?	0 and 8 weeks
Secondary	Functional muscle power test - hand pressure test	Does exercise intervention (physical activity) cause changes in muscle power of cancer patients on chemotherapy?	0 and 8 weeks
Secondary	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?	0 and 8 weeks
Secondary	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?	0 and 8 weeks
Secondary	Functional muscle power test - plank-test for the body	Does exercise intervention (physical activity) cause changes in muscle power of cancer patients on chemotherapy?	0 and 8 weeks
Secondary	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?	0 and 8 weeks