Development, ConsensusNCT05757362
Development of Compliance Questionnaire for Home Exercise Program
A study testing Compliance Questionnaire for Therapeutic Home Exercise Program in Physiotherapy and Rehabilitation (cq-HEPT) in people with Development, Consensus, run by Istanbul Bilgi University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Development, Consensus
- What is being tested?
- Compliance Questionnaire for Therapeutic Home Exercise Program in Physiotherapy and Rehabilitation (cq-HEPT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Apr 2023to 1 Sep 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Bilgi University
Istanbul, Beyoglu, 34440
About this study
Official title: 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.
Read the 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.
- Conditions
- Development, Consensus
- Being tested
- Compliance Questionnaire for Therapeutic Home Exercise Program in Physiotherapy and Rehabilitation (cq-HEPT)
- Keywords
- Delphi method, compliance, home exercise, questionnaire, validity, reliability
- Medical subject headings
- Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compliance Questionnaire for Therapeutic Home Exercise Program in Physiotherapy and Rehabilitation (cq-HEPT)Other
An online application of the developed questionnaire form
| Study group | Role | What they receive |
|---|---|---|
| Compliance Questionnaire for Therapeutic Home Exercise Program in Physiotherapy and Rehabilitation | Other | Participants will be asked to complete the questionnaire developed. Receives: Other: Compliance Questionnaire for Therapeutic Home Exercise Program in Physiotherapy and Rehabilitation (cq-HEPT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance Questionnaire for Therapeutic Home Exercise Program in Physiotherapy and Rehabilitation (CQ-HEPT)
The questionnaire planned to be developed by the investigators using the Delphi method
Measured: through study completion, an average of 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2023
- Study start24 Apr 2023
- Primary completion25 Jun 2023
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Development, ConsensusStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Bilgi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Elcin Dereli, Istanbul Bilgi University
- Investigators
- Elif E Dereli, Assoc. Prof., Study chair, Istanbul Bilgi UniversityTugba K Colak, Assoc. Prof., Study director, Marmara UniversityAycan C Reyhan, PhD, Principal investigator, Istanbul Bilgi UniversityCigdem Emirza, MSc, Principal investigator, Istanbul Bilgi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05757362
- Sponsor's protocol ID
- 202240034145
- Status last verified
- Apr 2025
- First submitted
- 26 Dec 2022
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Publications
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.
PubMed 15166072Jack B, Clarke AM. The purpose and use of questionnaires in research. Prof Nurse. 1998 Dec;14(3):176-9.
PubMed 10095687Lee 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.
PubMed 32020878Gagnon 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.
PubMed 24916892Antcliff 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.
PubMed 23395263Galloza 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.
PubMed 29031333Hotting 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.
PubMed 23623982Gimenez-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.
PubMed 32456164de 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.
PubMed 26626157Amatriain-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.
PubMed 32478537Moreno 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.
PubMed 31610889Nicolson 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.
PubMed 30053792Newman-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.
PubMed 27913064A 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
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Compliance Questionnaire for Therapeutic Home Exercise Program in Physiotherapy and Rehabilitation (CQ-HEPT) Using the Delphi Method
- ClinicalTrials.gov ID
- NCT05757362
- Acronym / sponsor ID
- 202240034145
- Conditions
- Development, Consensus
- Keywords
- Delphi method, compliance, home exercise, questionnaire, validity, reliability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Istanbul Bilgi UniversityUniversity, hospital or other
- Study start
- 24 Apr 2023 (actual)
- Primary completion
- 25 Jun 2023 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 7 Mar 2023 (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.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Compliance Questionnaire for Therapeutic Home Exercise Program in Physiotherapy and Rehabilitation | Other | Other: Compliance Questionnaire for Therapeutic Home Exercise Program in Physiotherapy and Rehabilitation (cq-HEPT)Participants will be asked to complete the questionnaire developed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Compliance Questionnaire for Therapeutic Home Exercise Program in Physiotherapy and Rehabilitation (cq-HEPT)An online application of the developed questionnaire form | Other | Compliance Questionnaire for Therapeutic Home Exercise Program in Physiotherapy and Rehabilitation |
Primary outcome
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
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 May 2025.
- Background: PubMed 15166072Boynton PM, Greenhalgh T. Selecting, designing, and developing your questionnaire. BMJ. 2004 May 29;328(7451):1312-5. doi: 10.1136/bmj.328.7451.1312.
- Background: PubMed 10095687Jack B, Clarke AM. The purpose and use of questionnaires in research. Prof Nurse. 1998 Dec;14(3):176-9.
- Background: PubMed 32020878Lee 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.
- Background: PubMed 24916892Gagnon 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.
- Background: PubMed 23395263Antcliff 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.
- Background: PubMed 29031333Galloza 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.
- Background: PubMed 23623982Hotting 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.
- Background: PubMed 32456164Gimenez-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.
- Background: PubMed 26626157de 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.
- Background: PubMed 32478537Amatriain-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.
- Background: PubMed 31610889Moreno 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.
- Background: PubMed 30053792Nicolson 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.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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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.
Elif E Dereli, Assoc. Prof. study chair
Istanbul Bilgi University
Tugba K Colak, Assoc. Prof. study director
Marmara University
Aycan C Reyhan, PhD principal investigator
Istanbul Bilgi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compliance Questionnaire for Therapeutic Home Exercise Program in Physiotherapy and Rehabilitation (cq-HEPT) in people with Development, Consensus, run by Istanbul Bilgi 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?
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 May 2025. 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?
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?
Compliance Questionnaire for Therapeutic Home Exercise Program in Physiotherapy and Rehabilitation (CQ-HEPT) (time frame: through study completion, an average of 6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05757362, which also lists 15 linked publications.
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 May 2025.