- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05757362
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
Completed
Conditions
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
Interventional
Enrollment (Actual)
50
Phase
- 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
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
Other: Compliance Questionnaire for Therapeutic Home Exercise Program in Physiotherapy and Rehabilitation
Participants will be asked to complete the questionnaire developed.
|
An online application of the developed questionnaire form
|
What is the study measuring?
Primary Outcome Measures
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
Investigators
- 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
- de Labra C, Guimaraes-Pinheiro C, Maseda A, Lorenzo T, Millan-Calenti JC. Effects of physical exercise interventions in frail older adults: a systematic review of randomized controlled trials. BMC Geriatr. 2015 Dec 2;15:154. doi: 10.1186/s12877-015-0155-4.
- Galloza J, Castillo B, Micheo W. Benefits of Exercise in the Older Population. Phys Med Rehabil Clin N Am. 2017 Nov;28(4):659-669. doi: 10.1016/j.pmr.2017.06.001.
- Boynton PM, Greenhalgh T. Selecting, designing, and developing your questionnaire. BMJ. 2004 May 29;328(7451):1312-5. doi: 10.1136/bmj.328.7451.1312.
- Jack B, Clarke AM. The purpose and use of questionnaires in research. Prof Nurse. 1998 Dec;14(3):176-9.
- Lee J, Lee SH, Chang GT. Expert consensus on the development of a health-related questionnaire for the pediatric field of Korean medicine: a Delphi study. BMC Complement Med Ther. 2020 Jan 15;20(1):10. doi: 10.1186/s12906-019-2796-x.
- Gagnon AJ, DeBruyn R, Essen B, Gissler M, Heaman M, Jeambey Z, Korfker D, McCourt C, Roth C, Zeitlin J, Small R; ROAM Collaboration. Development of the Migrant Friendly Maternity Care Questionnaire (MFMCQ) for migrants to Western societies: an international Delphi consensus process. BMC Pregnancy Childbirth. 2014 Jun 10;14:200. doi: 10.1186/1471-2393-14-200.
- Antcliff D, Keeley P, Campbell M, Oldham J, Woby S. The development of an activity pacing questionnaire for chronic pain and/or fatigue: a Delphi technique. Physiotherapy. 2013 Sep;99(3):241-6. doi: 10.1016/j.physio.2012.12.003. Epub 2013 Feb 8.
- Hotting K, Roder B. Beneficial effects of physical exercise on neuroplasticity and cognition. Neurosci Biobehav Rev. 2013 Nov;37(9 Pt B):2243-57. doi: 10.1016/j.neubiorev.2013.04.005. Epub 2013 Apr 25.
- Amatriain-Fernandez S, Murillo-Rodriguez ES, Gronwald T, Machado S, Budde H. Benefits of physical activity and physical exercise in the time of pandemic. Psychol Trauma. 2020 Aug;12(S1):S264-S266. doi: 10.1037/tra0000643. Epub 2020 Jun 1.
- Moreno Reyes P, Munoz Gutierrez C, Pizarro Mena R, Jimenez Torres S. [Effects of physical exercise on sleep quality, insomnia, and daytime sleepiness in the elderly. A literature review]. Rev Esp Geriatr Gerontol. 2020 Jan-Feb;55(1):42-49. doi: 10.1016/j.regg.2019.07.003. Epub 2019 Oct 12. Spanish.
- Nicolson PJA, Hinman RS, Wrigley TV, Stratford PW, Bennell KL. Self-reported Home Exercise Adherence: A Validity and Reliability Study Using Concealed Accelerometers. J Orthop Sports Phys Ther. 2018 Dec;48(12):943-950. doi: 10.2519/jospt.2018.8275. Epub 2018 Jul 27.
- Newman-Beinart NA, Norton S, Dowling D, Gavriloff D, Vari C, Weinman JA, Godfrey EL. The development and initial psychometric evaluation of a measure assessing adherence to prescribed exercise: the Exercise Adherence Rating Scale (EARS). Physiotherapy. 2017 Jun;103(2):180-185. doi: 10.1016/j.physio.2016.11.001. Epub 2016 Nov 9.
- A brief history of RAND [Internet]. Rand.org. [cited 2022 Dec 26]. Available from: https://www.rand.org/about/history.html
- Dalkey N, Helmer O. An experimental application of the DELPHI method to the use of experts. Manage Sci [Internet]. 1963;9(3):458-67. Available from: http://dx.doi.org/10.1287/mnsc.9.3.458
- Gimenez-Meseguer J, Tortosa-Martinez J, Cortell-Tormo JM. The Benefits of Physical Exercise on Mental Disorders and Quality of Life in Substance Use Disorders Patients. Systematic Review and Meta-Analysis. Int J Environ Res Public Health. 2020 May 23;17(10):3680. doi: 10.3390/ijerph17103680.
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)
April 24, 2023
Primary Completion (Actual)
June 25, 2023
Study Completion (Actual)
September 1, 2024
Study Registration Dates
First Submitted
December 26, 2022
First Submitted That Met QC Criteria
March 3, 2023
First Posted (Actual)
March 7, 2023
Study Record Updates
Last Update Posted (Actual)
May 2, 2025
Last Update Submitted That Met QC Criteria
April 29, 2025
Last Verified
April 1, 2025
More Information
Terms related to this study
Other Study ID 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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