- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05580120
Online-supervised Exercise Program in Elderly People With Diabetes
October 11, 2022 updated by: Nurten Terkes, Mehmet Akif Ersoy University
The Effect of an Online-supervised Exercise Program in Elderly People With Diabetes on Fasting Blood Sugar, Psychological Resilience, and Quality of Life: A Double Blind Randomize Controlled Trial
This study was conducted to determine the effect of an online-supervised exercise program on fasting blood sugar, psychological resilience, and quality of life in elderly people with diabetes.
A parallel-group, randomized controlled trial design was used.
The study was conducted in a public hospital with 70 patients with elderly type 2 diabetes between Nowember 2021 and May 2022.
A Personal Information Form, The Brief Resilience Scale and A Measure of Quality of Life in the Elderly were used to collect data.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
70
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
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Burdur, Turkey, 15000
- Burdur Mehmet Akif Ersoy University
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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
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Having a diagnosis of Type 2 diabetes mellitus for at least 6 months,
- Being aged >50 years,
- Receiving oral antidiabetic and/or insulin therapy,
- Having a smartphone or a computer,
- Volunteering to participate in the study,
Exclusion Criteria:
- Individuals who had type 2 DM, but were illiterate
- Had vision and hearing loss
- Did not volunteer to participate in the study
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: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Online-supervised exercise group
After the pre-tests (The Brief Resilience Scale, Quality of Life) , the patients were given online-supervised exercise education for 6 weeks.
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Participants in the online-supervised exercise group were provided with an online-supervised exercise program by using the video conferencing method three times a week for 6 weeks on the Zoom application.
The exercise program was carried out synchronously
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Experimental: The unsupervised-exercise training group
After the pre-tests (The Brief Resilience Scale, Quality of Life) , the patients were given unsupervised exercise education for 6 weeks.
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The unsupervised-exercise training group was informed about how to do the same exercises by another researcher, a nurse academician, on the online platform by using the lecturing method.
Each training intervention took approximately 30 minutes.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Brief Resilience Scale
Time Frame: 5 minute
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The scale was developed by Smith et al. to measure individuals' resilience levels and was adapted to Turkish by Doğan.
It is a one-dimensional 6-item measurement tool.
High scores obtained from the scale indicate that the individual's psychological resilience is good.
Cronbach's alpha internal consistency coefficient of the scale is .83.
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5 minute
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A Measure of Quality of Life in the Elderly
Time Frame: 5 minute
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This scale was developed by Hyde et al. in 2003 to measure the quality of life of the elderly.
It was adapted to Turkish society in 2014 by Türkoğlu and Adıbelli.
An increase in the total score indicates an increase in the quality of life.
The scale consists of two sub-dimensions, namely "perceived autonomy and satisfaction" and "perceived disability".
Cronbach's alpha value of the original scale is .91.
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5 minute
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Sabriye Ucan Yamac, PhD, Burdur Mehmet Akif Ersoy 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
- Ruiz-Roso MB, Knott-Torcal C, Matilla-Escalante DC, Garcimartin A, Sampedro-Nunez MA, Davalos A, Marazuela M. COVID-19 Lockdown and Changes of the Dietary Pattern and Physical Activity Habits in a Cohort of Patients with Type 2 Diabetes Mellitus. Nutrients. 2020 Aug 4;12(8):2327. doi: 10.3390/nu12082327.
- Duruturk N, Ozkoslu MA. Effect of tele-rehabilitation on glucose control, exercise capacity, physical fitness, muscle strength and psychosocial status in patients with type 2 diabetes: A double blind randomized controlled trial. Prim Care Diabetes. 2019 Dec;13(6):542-548. doi: 10.1016/j.pcd.2019.03.007. Epub 2019 Apr 20.
- Seron P, Oliveros MJ, Gutierrez-Arias R, Fuentes-Aspe R, Torres-Castro RC, Merino-Osorio C, Nahuelhual P, Inostroza J, Jalil Y, Solano R, Marzuca-Nassr GN, Aguilera-Eguia R, Lavados-Romo P, Soto-Rodriguez FJ, Sabelle C, Villarroel-Silva G, Gomolan P, Huaiquilaf S, Sanchez P. Effectiveness of Telerehabilitation in Physical Therapy: A Rapid Overview. Phys Ther. 2021 Jun 1;101(6):pzab053. doi: 10.1093/ptj/pzab053.
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)
November 15, 2021
Primary Completion (Actual)
May 10, 2022
Study Completion (Actual)
July 15, 2022
Study Registration Dates
First Submitted
October 7, 2022
First Submitted That Met QC Criteria
October 11, 2022
First Posted (Actual)
October 14, 2022
Study Record Updates
Last Update Posted (Actual)
October 14, 2022
Last Update Submitted That Met QC Criteria
October 11, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GO 2021/293
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
All authors contributed to the interpretation, writing, and approval of the final manuscript.
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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