Examination Of Exercise Adherence İn Lung Cancer Patients Given Calisthenic Exercise

April 12, 2022 updated by: Kardelen HATIMOĞULLARI, Hasan Kalyoncu University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Gaziantep, Turkey
        • Hasan Kalyoncu Univercity

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: physical activity counseling
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.
Active Comparator: training group
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.
Behavioral: Pyhsiohterapy and rehabilitation
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
8 week

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The functional capacity of patients with lung cancer who are given calisthenic exercise increases.
Time Frame: 8 week
The functional capacity of patients with lung cancer who are given calisthenic exercises under the guidance of a physiotherapist increases.
8 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hasan Kalyoncu University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 5, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 18, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 18, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2022/026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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