NCT05580120

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 7, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 14, 2022

Completed
Last Updated

October 14, 2022

Status Verified

October 1, 2022

Enrollment Period

6 months

First QC Date

October 7, 2022

Last Update Submit

October 11, 2022

Conditions

Keywords

psychological resiliencequality of lifedistance education

Outcome Measures

Primary Outcomes (2)

  • The Brief Resilience Scale

    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.

    5 minute

  • A Measure of Quality of Life in the Elderly

    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.

    5 minute

Study Arms (2)

Online-supervised exercise group

EXPERIMENTAL

After the pre-tests (The Brief Resilience Scale, Quality of Life) , the patients were given online-supervised exercise education for 6 weeks.

Behavioral: Online-supervised exercise group

The unsupervised-exercise training group

EXPERIMENTAL

After the pre-tests (The Brief Resilience Scale, Quality of Life) , the patients were given unsupervised exercise education for 6 weeks.

Behavioral: Unsupervised-exercise training group

Interventions

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

Online-supervised exercise group

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.

The unsupervised-exercise training group

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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,

You may not qualify if:

  • Individuals who had type 2 DM, but were illiterate
  • Had vision and hearing loss
  • Did not volunteer to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Burdur Mehmet Akif Ersoy University

Burdur, 15000, Turkey (Türkiye)

Location

Related Publications (3)

  • 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 Officials

  • Sabriye Ucan Yamac, PhD

    Burdur Mehmet Akif Ersoy University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
They did not know if they were in the control and intervention group at the time of randomization.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 7, 2022

First Posted

October 14, 2022

Study Start

November 15, 2021

Primary Completion

May 10, 2022

Study Completion

July 15, 2022

Last Updated

October 14, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

All authors contributed to the interpretation, writing, and approval of the final manuscript.

Locations