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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05147883
Other study ID # EFEXQULS
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 1, 2021
Est. completion date December 1, 2022

Study information

Verified date December 2021
Source Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Contact Elif Yildirim Ayaz, M.D.
Phone +905325148300
Email drelifyildirim@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to determine the effect of exercise on quality of life, sleep quality and anxiety in patients with prediabetes.


Description:

Randomized controlled studies are needed to examine the effects of exercise on sleep quality, quality of life, anxiety and depression in patients with prediabetes. The aim of this study is to determine the effect of exercise on quality of life, sleep quality and anxiety in patients with prediabetes.


Recruitment information / eligibility

Status Recruiting
Enrollment 90
Est. completion date December 1, 2022
Est. primary completion date December 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 59 Years
Eligibility Inclusion Criteria: - 18-59 years old - Living a sedentary life (physical activity below 300 kcal/day will be evaluated with the Minnesota Leisure Physical Activity Questionnaire) - Those who have sufficient motivation to participate in the exercise program (will be evaluated by a one-on-one interview by the researchers) - Those diagnosed with prediabetes by oral glucose tolerance test and/or HbA1c measurement will be included. - Being eligible to participate in an exercise program after a cardiac examination (resting ECG and questioning of cardiac symptoms, advanced tests such as exercise ECG test if necessary) performed by the physician Exclusion Criteria: - Serious medical condition (for example, advanced malignancy or major neurological, psychiatric or endocrine disease, respiratory failure, etc.) that would prevent the person from participating in exercise training. - Having cardiovascular disease - Being diabetic - Receiving hormone replacement therapy - Life expectancy less than 1 year - HIV positivity - Substance use - Functional dependency - Cognitive weakness - Those who have other diseases that will affect the results of the study (respiratory diseases, muscle diseases, etc.) - Those who use drugs or supplements that will affect the results of the study

Study Design


Intervention

Behavioral:
Exercise
Patients will be given an aerobic exercise program for 1 hour, 3 days a week for 12 weeks

Locations

Country Name City State
Turkey Sultan Abdülhamid Training and Research Hospital Istanbul Uskudar

Sponsors (1)

Lead Sponsor Collaborator
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Score of Quality of Life Quality of Life evaluated with Health-Related Short Form-36 Survey(Min-Max:0-100). High score idicates high quality of life. 1 week
Secondary Sleep Quality Sleep Quality evaluated with Pitssburgh Sleep Quality Index (PSQI) (Min-max: 0-100). High score indicates worse sleep quality. 1 week
Secondary Anxiety Anxiety evaluated with Hospital Anxiety Depression Scale (HADS) (Min-max:0-21). high score indicates high anxiety. 1 week
Secondary Depression Depression evaluated with Hospital Anxiety Depression Scale (HADS). (Min-max:0-21). high score indicates high depression. 1 week
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