Exercise AddictionNCT05332171
Examination Of Exercise Adherence İn Lung Cancer Patients Given Calisthenic Exercise
A study testing Pyhsiohterapy and rehabilitation in people with Exercise Addiction and Lung Cancer, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
Trial summary
Cancer treatments usually include surgery, chemotherapy, radiation therapy, hormone therapy, and/or a combination of these methods. These treatments cause many physical and psychological effects that interfere with functional independence, performing activities of daily living, and healthy quality of life. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Exercise Addiction, Lung Cancer
- What is being tested?
- Pyhsiohterapy and rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Apr 2022to Aug 2022
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients whose chemotherapy and radiotherapy has ended, at least 6 months and maximum 5 years after surgery
- Being between the ages of 18-65
- 3 and 5 years according to the Modified Borg Scale Patients with severe fatigue
Who cannot join
- Uncontrollable hypertension, diabetes mellitus, heart failure and atrial fibrillation
- Any acute infection during the evaluation
- Orthopedic, neurological, psychological, etc., which will limit the evaluations. with problems
Trial locations and contacts
1 site in 1 country.
About this study
Cancer treatments usually include surgery, chemotherapy, radiation therapy, hormone therapy, and/or a combination of these methods. These treatments cause many physical and psychological effects that interfere with functional independence, performing activities of daily living, and healthy quality of life. Mostly, depending on cancer and its treatment; Cognitive function, sleep pattern, functional capacity, pain state and bone mineral density are affected. Exercise compliance is the degree to which an individual's behavior is consistent with the health care provider's advice and treatment plan. According to the World Health Organization, compliance is "a measure of a person's behavior (such as following a recommended exercise program, monitoring drug intake, etc.). ) as a response to complying with recommendations deemed appropriate by health care professionals''. In the field of rehabilitation too, compliance is increasingly used in relation to the self-management of patients' health. It has been stated in the studies that the level of compliance with the recommended home exercise is generally low, which limits the benefits of exercise programs.
Read the detailed description
This study is a cross-sectional study. Lung cancer patients who applied to the Oncology Service and met the inclusion criteria will be included in the study. Patients will be randomly assigned to physical activity counseling and education groups.
Within the scope of the study, exercise compliance will be examined in patients with lung cancer who are given calisthenic exercise.
Participants will be evaluated before treatment, their functional capacities will be determined, their compliance with exercise, fatigue levels, pain levels, cognitive status, sleep and quality of life will be evaluated with questionnaires.
Home exercises will be taught to the physical activity counseling group and will be followed up under the supervision of a physiotherapist with weekly controls. Breathing exercises and calisthenic exercises will be taught to the training group, and participants will be followed under the supervision of a physiotherapist for 8 weeks, 3 days a week. Evaluations will be made before and after the treatment.
Individuals who do not agree to / give up participating in the study will be able to leave the study voluntarily.
All information belonging to individuals will be protected according to the personal data protection law.
- Conditions
- Exercise Addiction, Lung Cancer
- Being tested
- Pyhsiohterapy and rehabilitation
- Keywords
- Lung Cancer, Pulmonary Rehabilitation, calisthenic exercise, exercise adherence
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pyhsiohterapy and rehabilitationBehavioural
Before starting the exercise program, 10 repetitive warm-up exercises will be given including the lower and upper extremities and distal joints. The exercises will be started with 5 repetitions in the first week. Depending on the patient's tolerance, the intensity of the exercise will be increased as 10 repetitions, 15 repetitions and 20 repetitions, and optional rest will be allowed between exercises. It is aimed that the patients reach 20 repetitions in the 6th week at the latest.
| Study group | Role | What they receive |
|---|---|---|
| physical activity counseling | No intervention | Home exercises will be taught to the physical activity counseling group and will be followed up under the supervision of a physiotherapist with weekly controls. Evaluation will be done before and after treatment. |
| training group | Active comparator | Breathing exercises and calisthenic exercises will be taught to the training group, and they will be followed under the supervision of a physiotherapist for 8 weeks, 3 days a week. Evaluations will be made before and after treatment. Individuals in the calisthenic exercise group will be given exercise training at the level of 65%-80% of the maximal heart rate for 30-40 minutes, 3 days a week for 8 weeks. Receives: Behavioral: Pyhsiohterapy and rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise compliance of patients with lung cancer who are given calisthenic exercise increases
Exercise compliance increases in patients who are given calisthenic exercises accompanied by a physiotherapist.
Measured: 8 week
Secondary outcomes (1)
The functional capacity of patients with lung cancer who are given calisthenic exercise increases.
The functional capacity of patients with lung cancer who are given calisthenic exercises under the guidance of a physiotherapist increases.
Measured: 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2022
- Study startApr 2022 (estimated)
- Primary completionJun 2022 (estimated)
- Study completionAug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise AddictionStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- It is aimed to evaluate patients with Lung Cancer who meet the inclusion criteria of the study. Individuals will be randomly assigned to physical activity counseling and training groups. The number of participants in the groups will be determined by power analysis. Criteria for inclusion in the study; * Patients whose chemotherapy and radiotherapy has ended, at least 6 months and maximum 5 years after surgery * Being between the ages of 18-65 * 3 and 5 years according to the Modified Borg Scale Patients with severe fatigue Exclusion criteria; * Uncontrollable hypertension, diabetes mellitus, heart failure and atrial fibrillation * Any acute infection during the evaluation * Orthopedic, neurological, psychological, etc., which will limit the evaluations. with problems
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hasan Kalyoncu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kardelen HATIMOĞULLARI, Hasan Kalyoncu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05332171
- Sponsor's protocol ID
- 2022/026
- Status last verified
- Apr 2022
- First submitted
- 5 Apr 2022
- Last updated
- 18 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination Of Exercise Adherence İn Lung Cancer Patients Given Calisthenic Exercise
- ClinicalTrials.gov ID
- NCT05332171
- Acronym / sponsor ID
- 2022/026
- Conditions
- Exercise Addiction, Lung Cancer
- Keywords
- Lung Cancer, Pulmonary Rehabilitation, calisthenic exercise, exercise adherence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hasan Kalyoncu UniversityUniversity, hospital or other
- Study start
- Apr 2022 (estimated)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 18 Apr 2022 (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.
Cancer treatments usually include surgery, chemotherapy, radiation therapy, hormone therapy, and/or a combination of these methods. These treatments cause many physical and psychological effects that interfere with functional independence, performing activities of daily living, and healthy quality of life. Mostly, depending on cancer and its treatment; Cognitive function, sleep pattern, functional capacity, pain state and bone mineral density are affected. Exercise compliance is the degree to which an individual's behavior is consistent with the health care provider's advice and treatment plan. According to the World Health Organization, compliance is "a measure of a person's behavior (such as following a recommended exercise program, monitoring drug intake, etc.). ) as a response to complying with recommendations deemed appropriate by health care professionals''. In the field of rehabilitation too, compliance is increasingly used in relation to the self-management of patients' health. It has been stated in the studies that the level of compliance with the recommended home exercise is generally low, which limits the benefits of exercise programs.
Detailed description
This study is a cross-sectional study. Lung cancer patients who applied to the Oncology Service and met the inclusion criteria will be included in the study. Patients will be randomly assigned to physical activity counseling and education groups.
Within the scope of the study, exercise compliance will be examined in patients with lung cancer who are given calisthenic exercise.
Participants will be evaluated before treatment, their functional capacities will be determined, their compliance with exercise, fatigue levels, pain levels, cognitive status, sleep and quality of life will be evaluated with questionnaires.
Home exercises will be taught to the physical activity counseling group and will be followed up under the supervision of a physiotherapist with weekly controls. Breathing exercises and calisthenic exercises will be taught to the training group, and participants will be followed under the supervision of a physiotherapist for 8 weeks, 3 days a week. Evaluations will be made before and after the treatment.
Individuals who do not agree to / give up participating in the study will be able to leave the study voluntarily.
All information belonging to individuals will be protected according to the personal data protection law.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- It is aimed to evaluate patients with Lung Cancer who meet the inclusion criteria of the study. Individuals will be randomly assigned to physical activity counseling and training groups. The number of participants in the groups will be determined by power analysis. Criteria for inclusion in the study; * Patients whose chemotherapy and radiotherapy has ended, at least 6 months and maximum 5 years after surgery * Being between the ages of 18-65 * 3 and 5 years according to the Modified Borg Scale Patients with severe fatigue Exclusion criteria; * Uncontrollable hypertension, diabetes mellitus, heart failure and atrial fibrillation * Any acute infection during the evaluation * Orthopedic, neurological, psychological, etc., which will limit the evaluations. with problems
| Arm | Type | Receives |
|---|---|---|
| physical activity counseling | No intervention | –Home exercises will be taught to the physical activity counseling group and will be followed up under the supervision of a physiotherapist with weekly controls. Evaluation will be done before and after treatment. |
| training group | Active comparator | Behavioral: Pyhsiohterapy and rehabilitationBreathing exercises and calisthenic exercises will be taught to the training group, and they will be followed under the supervision of a physiotherapist for 8 weeks, 3 days a week. Evaluations will be made before and after treatment. Individuals in the calisthenic exercise group will be given exercise training at the level of 65%-80% of the maximal heart rate for 30-40 minutes, 3 days a week for 8 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients whose chemotherapy and radiotherapy has ended, at least 6 months and maximum 5 years after surgery
- Being between the ages of 18-65
- 3 and 5 years according to the Modified Borg Scale Patients with severe fatigue
Key exclusion criteria (3 listed)
- Uncontrollable hypertension, diabetes mellitus, heart failure and atrial fibrillation
- Any acute infection during the evaluation
- Orthopedic, neurological, psychological, etc., which will limit the evaluations. with problems
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 |
|---|---|---|
| Pyhsiohterapy and rehabilitationBefore starting the exercise program, 10 repetitive warm-up exercises will be given including the lower and upper extremities and distal joints. The exercises will be started with 5 repetitions in the first week. Depending on the patient's tolerance, the intensity of the exercise will be increased as 10 repetitions, 15 repetitions and 20 repetitions, and optional rest will be allowed between exercises. It is aimed that the patients reach 20 repetitions in the 6th week at the latest. | Behavioural | training group |
Primary outcome
Exercise compliance of patients with lung cancer who are given calisthenic exercise increases
Time frame: 8 week
Exercise compliance increases in patients who are given calisthenic exercises accompanied by a physiotherapist.
1 secondary outcome
The functional capacity of patients with lung cancer who are given calisthenic exercise increases.
Time frame: 8 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2022.
- Individual participant dataSharing planned: Undecided
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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 Pyhsiohterapy and rehabilitation in people with Exercise Addiction and Lung Cancer, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 18 Apr 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 Turkey (Türkiye). 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?
Results are not available in the source record.
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?
Exercise compliance of patients with lung cancer who are given calisthenic exercise increases (time frame: 8 week). 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 18 Apr 2022.