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

NCT ID: NCT05147883

Last Updated: 2021-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-01

Study Completion Date

2022-12-01

Brief Summary

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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

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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.

Conditions

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PreDiabetes Physical Inactivity Quality of Life Sleep Anxiety Depression

Keywords

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PreDiabetes Physical Inactivity Quality of Life Sleep Anxiety Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Exercise

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

Group Type EXPERIMENTAL

Exercise

Intervention Type BEHAVIORAL

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

Control

No intervention will be applied to the patients

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Exercise

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

OTHER

Sponsor Role lead

Responsible Party

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Elif Yıldırım Ayaz

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Elif Yıldırım Ayaz, M.D.

Role: PRINCIPAL_INVESTIGATOR

Sultan Abdülhamid Training And Research Hospital

Locations

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Sultan Abdülhamid Training and Research Hospital

Istanbul, Uskudar, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Elif Yıldırım Ayaz, M.D.

Role: CONTACT

Phone: +905325148300

Email: [email protected]

Facility Contacts

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Elif Yıldırım Ayaz, M.D.

Role: primary

Other Identifiers

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EFEXQULS

Identifier Type: -

Identifier Source: org_study_id