NCT05147883

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 23, 2021

Completed
8 days until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 7, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

December 29, 2021

Status Verified

December 1, 2021

Enrollment Period

1 year

First QC Date

November 23, 2021

Last Update Submit

December 28, 2021

Conditions

PreDiabetesPhysical InactivityQuality of LifeSleepAnxietyDepression

Keywords

PreDiabetesPhysical InactivityQuality of LifeSleepAnxietyDepression

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Sleep Quality

    1 week

  • Anxiety

    1 week

  • Depression

    1 week

Study Arms (2)

Exercise

EXPERIMENTAL

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

Behavioral: Exercise

Control

NO INTERVENTION

No intervention will be applied to the patients

Interventions

ExerciseBEHAVIORAL

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

Exercise

Eligibility Criteria

Age18 Years - 59 Years
Sexall(Gender-based eligibility)
Gender Eligibility Details18-59 years
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sultan Abdülhamid Training and Research Hospital

Istanbul, Uskudar, 34366, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Prediabetic StateSedentary BehaviorAnxiety DisordersDepression

Interventions

Exercise

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehaviorMental DisordersBehavioral Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Elif Yıldırım Ayaz, M.D.

    Sultan Abdülhamid Training And Research Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Elif Yıldırım Ayaz, M.D.

CONTACT

+905325148300drelifyildirim@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 23, 2021

First Posted

December 7, 2021

Study Start

December 1, 2021

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

December 29, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)