CancerNCT04151238
Exercise Intervention for Cancer Patients
A study testing Exercise intervention for cancer patients to increase physical activity during chemotherapy in people with Cancer, run by Turku University Hospital at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cancer
- What is being tested?
- Exercise intervention for cancer patients to increase physical activity during chemotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteFinland
- Study dates
- 17 Feb 2020to 8 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- z=0-1 (no aids)
- capable travelling to University hospital for 8 weeks twice a week
- normal or poor physical activity background
Who cannot join
- 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"
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exercise Intervention for Cancer Patients to Increase Physical Activity During Chemotherapy
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.
- Conditions
- Cancer
- Being tested
- Exercise intervention for cancer patients to increase physical activity during chemotherapy
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise intervention for cancer patients to increase physical activity during chemotherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise intervention | Experimental | 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. Receives: Behavioral: Exercise intervention for cancer patients to increase physical activity during chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 0 and 8 weeks,
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.
Measured: 0 and 8 weeks
Secondary outcomes (10)
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.
Measured: 0 and 8 weeks
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.
Measured: 0 and 8 weeks
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.
Measured: 0 and 8 weeks
Endurance (submaximal treadmill test)
Does exercise intervention (physical activity) cause changes in endurance of cancer patients on chemotherapy?
Measured: 0 and 8 weeks
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?
Measured: 0 and 8 weeks
Functional muscle power test - hand pressure test
Does exercise intervention (physical activity) cause changes in muscle power of cancer patients on chemotherapy?
Measured: 0 and 8 weeks
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?
Measured: 0 and 8 weeks
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?
Measured: 0 and 8 weeks
Functional muscle power test - plank-test for the body
Does exercise intervention (physical activity) cause changes in muscle power of cancer patients on chemotherapy?
Measured: 0 and 8 weeks
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?
Measured: 0 and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study start17 Feb 2020
- Primary completion16 Apr 2020
- Study completion8 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Collaborators
- Turku AMK Master School
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04151238
- Sponsor's protocol ID
- T306/2019
- Status last verified
- Nov 2022
- First submitted
- 14 Oct 2019
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Intervention for Cancer Patients to Increase Physical Activity During Chemotherapy
- ClinicalTrials.gov ID
- NCT04151238
- Acronym / sponsor ID
- T306/2019
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Turku University HospitalOther government
- Collaborators
- Turku AMK Master School
- Study start
- 17 Feb 2020 (actual)
- Primary completion
- 16 Apr 2020 (actual)
- Study completion
- 8 May 2020 (actual)
- First posted
- 5 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise intervention | Experimental | Behavioral: Exercise intervention for cancer patients to increase physical activity during chemotherapyThe 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise intervention for cancer patients to increase physical activity during chemotherapyThe 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. | Behavioural | Exercise intervention |
Primary outcome
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.
10 secondary outcomes
Quality of life questionnaire (EORTC QLQ-c30)
Time frame: 0 and 8 weeks
Fatigue questionnaire (FACIT-F)
Time frame: 0 and 8 weeks
Body composition in cancer patients general view (In-Body-device)
Time frame: 0 and 8 weeks
Endurance (submaximal treadmill test)
Time frame: 0 and 8 weeks
Functional muscle power test - dynamic elevation test for upper arms
Time frame: 0 and 8 weeks
Functional muscle power test - hand pressure test
Time frame: 0 and 8 weeks
Functional muscle power test - the lower extremities by repeated squatting-standing
Time frame: 0 and 8 weeks
Functional muscle power test - the lower extremities by rising to stand on the toes
Time frame: 0 and 8 weeks
Functional muscle power test - plank-test for the body
Time frame: 0 and 8 weeks
Balance -tests in specific sway-platform (standing with both legs and only one leg in sway-platform)
Time frame: 0 and 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise intervention for cancer patients to increase physical activity during chemotherapy in people with Cancer, run by Turku University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
physical activity changes in diary (time frame: 0 and 8 weeks,). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2022.