PreDiabetesEFEXQULSNCT05147883
The Effect of Exercise on Quality of Life, Sleep Quality and Anxiety in Patients With Prediabetes (EFEXQULS)
A study testing Exercise in people with PreDiabetes and Physical Inactivity, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- PreDiabetes, Physical Inactivity, Quality of Life
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2021to 1 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Sultan Abdülhamid Training and Research Hospital
Istanbul, Uskudar, 34366
Elif Yıldırım Ayaz, M.D.
About this study
The aim of this study is to determine the effect of exercise on quality of life, sleep quality and anxiety in patients with prediabetes.
Read the 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.
- Conditions
- PreDiabetes, Physical Inactivity, Quality of Life, Sleep, Anxiety, Depression
- Being tested
- Exercise
- Keywords
- PreDiabetes, Physical Inactivity, Quality of Life, Sleep, Anxiety, Depression
- Medical subject headings
- Prediabetic State, Sedentary Behavior, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Patients will be given an aerobic exercise program for 1 hour, 3 days a week for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Patients will be given an aerobic exercise program for 1 hour, 3 days a week for 12 weeks. Receives: Behavioral: Exercise |
| Control | No intervention | No intervention will be applied to the patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 week
Secondary outcomes (3)
Sleep Quality
Sleep Quality evaluated with Pitssburgh Sleep Quality Index (PSQI) (Min-max: 0-100). High score indicates worse sleep quality.
Measured: 1 week
Anxiety
Anxiety evaluated with Hospital Anxiety Depression Scale (HADS) (Min-max:0-21). high score indicates high anxiety.
Measured: 1 week
Depression
Depression evaluated with Hospital Anxiety Depression Scale (HADS). (Min-max:0-21). high score indicates high depression.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2021
- Study start1 Dec 2021
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreDiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Yıldırım Ayaz, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Investigators
- Elif Yıldırım Ayaz, M.D., Principal investigator, Sultan Abdülhamid Training And Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05147883
- Sponsor's protocol ID
- EFEXQULS
- Acronym
- EFEXQULS
- Status last verified
- Dec 2021
- First submitted
- 23 Nov 2021
- Last updated
- 29 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Exercise on Quality of Life, Sleep Quality and Anxiety in Patients With Prediabetes (EFEXQULS)
- ClinicalTrials.gov ID
- NCT05147883
- Acronym / sponsor ID
- EFEXQULS / EFEXQULS
- Conditions
- PreDiabetes, Physical Inactivity, Quality of Life, Sleep, Anxiety, Depression
- Keywords
- PreDiabetes, Physical Inactivity, Quality of Life, Sleep, Anxiety, Depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, TurkeyUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 7 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: ExercisePatients will be given an aerobic exercise program for 1 hour, 3 days a week for 12 weeks. |
| Control | No intervention | –No intervention will be applied to the patients |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExercisePatients will be given an aerobic exercise program for 1 hour, 3 days a week for 12 weeks | Behavioural | Exercise |
Primary outcome
Score of Quality of Life
Time frame: 1 week
Quality of Life evaluated with Health-Related Short Form-36 Survey(Min-Max:0-100). High score idicates high quality of life.
3 secondary outcomes
Sleep Quality
Time frame: 1 week
Anxiety
Time frame: 1 week
Depression
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elif Yıldırım Ayaz, M.D. principal investigator
Sultan Abdülhamid Training And Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with PreDiabetes and Physical Inactivity, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elif Yıldırım Ayaz, M.D. (+905325148300, drelifyildirim@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score of Quality of Life (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2021.