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

Primary Purpose

PreDiabetes, Physical Inactivity, Quality of Life

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Exercise
Sponsored by
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for PreDiabetes focused on measuring PreDiabetes, Physical Inactivity, Quality of Life, Sleep, Anxiety, Depression

Eligibility Criteria

18 Years - 59 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sultan Abdülhamid Training and Research HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exercise

Control

Arm Description

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

No intervention will be applied to the patients

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
November 23, 2021
Last Updated
December 28, 2021
Sponsor
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
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1. Study Identification

Unique Protocol Identification Number
NCT05147883
Brief Title
The Effect of Exercise on Quality of Life, Sleep Quality and Anxiety in Patients With Prediabetes (EFEXQULS)
Acronym
EFEXQULS
Official Title
The Effect of Exercise on Quality of Life, Sleep Quality and Anxiety in Patients With Prediabetes (EFEXQULS)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PreDiabetes, Physical Inactivity, Quality of Life, Sleep, Anxiety, Depression
Keywords
PreDiabetes, Physical Inactivity, Quality of Life, Sleep, Anxiety, Depression

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise
Arm Type
Experimental
Arm Description
Patients will be given an aerobic exercise program for 1 hour, 3 days a week for 12 weeks.
Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention will be applied to the patients
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
Patients will be given an aerobic exercise program for 1 hour, 3 days a week for 12 weeks
Primary Outcome Measure Information:
Title
Score of Quality of Life
Description
Quality of Life evaluated with Health-Related Short Form-36 Survey(Min-Max:0-100). High score idicates high quality of life.
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Sleep Quality
Description
Sleep Quality evaluated with Pitssburgh Sleep Quality Index (PSQI) (Min-max: 0-100). High score indicates worse sleep quality.
Time Frame
1 week
Title
Anxiety
Description
Anxiety evaluated with Hospital Anxiety Depression Scale (HADS) (Min-max:0-21). high score indicates high anxiety.
Time Frame
1 week
Title
Depression
Description
Depression evaluated with Hospital Anxiety Depression Scale (HADS). (Min-max:0-21). high score indicates high depression.
Time Frame
1 week

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
18-59 years
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elif Yıldırım Ayaz, M.D.
Phone
+905325148300
Email
drelifyildirim@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elif Yıldırım Ayaz, M.D.
Organizational Affiliation
Sultan Abdülhamid Training And Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sultan Abdülhamid Training and Research Hospital
City
Istanbul
State/Province
Uskudar
ZIP/Postal Code
34366
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elif Yıldırım Ayaz, M.D.

12. IPD Sharing Statement

Plan to Share IPD
No

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

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