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

Sponsor
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey (Other)
Overall Status
Recruiting
CT.gov ID
NCT05147883
Collaborator
(none)
90
1
2
12
7.5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Exercise
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
The Effect of Exercise on Quality of Life, Sleep Quality and Anxiety in Patients With Prediabetes (EFEXQULS)
Actual Study Start Date :
Dec 1, 2021
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Exercise

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

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

No Intervention: Control

No intervention will be applied to the patients

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Sleep Quality [1 week]

    Sleep Quality evaluated with Pitssburgh Sleep Quality Index (PSQI) (Min-max: 0-100). High score indicates worse sleep quality.

  2. Anxiety [1 week]

    Anxiety evaluated with Hospital Anxiety Depression Scale (HADS) (Min-max:0-21). high score indicates high anxiety.

  3. Depression [1 week]

    Depression evaluated with Hospital Anxiety Depression Scale (HADS). (Min-max:0-21). high score indicates high depression.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 59 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sultan Abdülhamid Training and Research Hospital Istanbul Uskudar Turkey 34366

Sponsors and Collaborators

  • Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Investigators

  • Principal Investigator: Elif Yıldırım Ayaz, M.D., Sultan Abdülhamid Training And Research Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Elif Yıldırım Ayaz, Principal Investigator, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
ClinicalTrials.gov Identifier:
NCT05147883
Other Study ID Numbers:
  • EFEXQULS
First Posted:
Dec 7, 2021
Last Update Posted:
Dec 29, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Elif Yıldırım Ayaz, Principal Investigator, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 29, 2021