The Effect of Exercise on Quality of Life, Sleep Quality and Anxiety in Patients With Prediabetes (EFEXQULS)

Depression Clinical Trial

— EFEXQULS  

Official title:

The Effect of Exercise on Quality of Life, Sleep Quality and Anxiety in Patients With Prediabetes (EFEXQULS)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05147883
• Other study ID #: EFEXQULS
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Depression
• Glucose Intolerance
• Physical Inactivity
• PreDiabetes
• Prediabetic State
• Quality of Life
• Sleep

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