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

Not Applicable

• Conditions: Physical Inactivity; Sleep; Depression; Quality of Life; PreDiabetes; Anxiety
• Interventions: Behavioral: Exercise

• Registration Number: NCT05147883
• Lead Sponsor: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2021-11-23
• Study First Submitted QC: 2021-11-23
• Status Verified: 2021-12
• Study Start: 2021-12-01
• Study First Posted: 2021-12-07
• Last Update Submitted: 2021-12-28
• Last Update Posted: 2021-12-29
• Primary Completion: 2022-12-01
• Study Completion: 2022-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise	Exercise	Patients will be given an aerobic exercise program for 1 hour, 3 days a week for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Score of Quality of Life	1 week	Quality of Life evaluated with Health-Related Short Form-36 Survey(Min-Max:0-100). High score idicates high quality of life.

Secondary Outcome Measures

Name	Time	Method
Sleep Quality	1 week	Sleep Quality evaluated with Pitssburgh Sleep Quality Index (PSQI) (Min-max: 0-100). High score indicates worse sleep quality.
Anxiety	1 week	Anxiety evaluated with Hospital Anxiety Depression Scale (HADS) (Min-max:0-21). high score indicates high anxiety.
Depression	1 week	Depression evaluated with Hospital Anxiety Depression Scale (HADS). (Min-max:0-21). high score indicates high depression.

Trial Locations

Locations (1)

Sultan Abdülhamid Training and Research Hospital; 🇹🇷 Istanbul, Uskudar, Turkey