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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05757362
Other study ID # 202240034145
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 24, 2023
Est. completion date September 2024

Study information

Verified date December 2023
Source Istanbul Bilgi University
Contact Elif E Dereli, Assoc. Prof.
Phone +905303791554
Email elcin.dereli@bilgi.edu.tr
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date September 2024
Est. primary completion date June 25, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Compliance Questionnaire for Therapeutic Home Exercise Program in Physiotherapy and Rehabilitation (cq-HEPT)
An online application of the developed questionnaire form

Locations

Country Name City State
Turkey Istanbul Bilgi University Istanbul Beyoglu

Sponsors (1)

Lead Sponsor Collaborator
Istanbul Bilgi University

Country where clinical trial is conducted

Turkey, 

References & Publications (15)

A brief history of RAND [Internet]. Rand.org. [cited 2022 Dec 26]. Available from: https://www.rand.org/about/history.html

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: Int J Environ Res Public Health. 2020 Jul 17;17(14): — View Citation

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. — View Citation

Jack B, Clarke AM. The purpose and use of questionnaires in research. Prof Nurse. 1998 Dec;14(3):176-9. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 15 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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 through study completion, an average of 6 months.
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