Development of Compliance Questionnaire for Home Exercise Program

April 29, 2025 updated by: Elif Elcin Dereli, Istanbul Bilgi University

Development of a Compliance Questionnaire for Therapeutic Home Exercise Program in Physiotherapy and Rehabilitation (CQ-HEPT) Using the Delphi Method

Exercise is a valuable basic treatment method in the field of physiotherapy and rehabilitation. However, the effectiveness of exercise therapy requires the individual to be attentive, compliant, and disciplined. Therefore, it is important to examine the factors that may affect compliance with exercise. The main aim of this study is to develop a questionnaire that can describe individuals' compliance with participation in a home exercise program using the Delphi method and then analyze the psychometric validity and reliability of this questionnaire. The value that the evaluation questionnaire planned to be obtained at the end of such a study will add to exercise science, which is one of the most powerful treatment elements of physiotherapy and rehabilitation discipline, is important.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

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

Exercise is a valuable basic treatment method in the discipline of physiotherapy and rehabilitation. The importance of exercise in maintaining and improving health or in combating diseases and/or injuries has been recognized. However, exercise therapy requires care, compliance, and discipline, otherwise, it is not possible to achieve positive results from this type of treatment. Examining factors that affect adherence to exercise can help understand and resolve issues that may hinder individual participation. The planned aim of this study was to develop a questionnaire that could describe individuals' compliance with participation in a home exercise program using the Delphi method, and then analyze the psychometric validity and reliability of this questionnaire. For this reason, academic physiotherapists or physiotherapists with at least 5 years of clinical experience will be asked to identify questions and details that can assess individuals' compliance with home exercise. Based on their responses, a questionnaire with at least 10 questions will be prepared by the investigators. Then, the appropriateness of the questions of this questionnaire will be examined and presented to the expert opinions again. The participating experts will be asked to rate each item sent to them on a Likert-type scale of 1 (strongly disagree) to 5 (strongly agree) whether it should be included in the questionnaire. If there is 80% or more consensus on an item for 4 and 5, the item will be considered to have reached consensus. Once the questionnaire has been created based on the Delphi method, it will be administered as an online questionnaire to 50 volunteer participants who have been given a home exercise program within physiotherapy and rehabilitation treatment and thus the basic psychometric properties of the questionnaire (internal consistency, test-retest reliability) will be analyzed. The evaluation questionnaire planned to be obtained at the end of this study is expected to significantly contribute to the field of exercise science.

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 (Actual)

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.
50

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Turkey
    • Beyoglu
      • Istanbul, Beyoglu, Turkey, 34440
        • Istanbul Bilgi University

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion criteria for the Delphi rounds are individuals who meet at least one of the following criteria:

  • Five or more years of professional experience in the field of Physiotherapy and Rehabilitation.
  • Holding an academic position in the field of Physiotherapy and Rehabilitation.

For testing the obtained questionnaire,

The inclusion criteria are:

  • To have recently or previously taken a home exercise program
  • To be over 18 years old

The exclusion criteria are:

-To have a condition that prevents the individual from understanding and completing the online questionnaire.

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: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

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.
Other: Compliance Questionnaire for Therapeutic Home Exercise Program in Physiotherapy and Rehabilitation
Participants will be asked to complete the questionnaire developed.
Other: Compliance Questionnaire for Therapeutic Home Exercise Program in Physiotherapy and Rehabilitation (cq-HEPT)
An online application of the developed questionnaire form

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
Compliance Questionnaire for Therapeutic Home Exercise Program in Physiotherapy and Rehabilitation (CQ-HEPT)
Time Frame: through study completion, an average of 6 months.
The questionnaire planned to be developed by the investigators using the Delphi method
through study completion, an average of 6 months.

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.
Istanbul Bilgi University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Elif E Dereli, Assoc. Prof., Istanbul Bilgi University
  • Study Director: Tugba K Colak, Assoc. Prof., Marmara University
  • Principal Investigator: Aycan C Reyhan, PhD, Istanbul Bilgi University
  • Principal Investigator: Cigdem Emirza, MSc, Istanbul Bilgi University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

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 24, 2023

Primary Completion (Actual)

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 25, 2023

Study Completion (Actual)

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.
September 1, 2024

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).
December 26, 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.
March 3, 2023

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.
March 7, 2023

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.
May 2, 2025

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 29, 2025

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, 2025

More Information

Terms related to this study

Keywords

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.
  • 202240034145

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is not a plan to make IPD available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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