- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07484399
Comparing Effects of HIIT and MICT on Functional Mobility, Muscle Strength, and Quality of Life in Diabetic Patients
Comparing The Effects of High Intensity Interval Training and Moderate Intensity Continuous Training on Functional Mobility, Muscle Strength, and Quality of Life in Diabetic Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Comparing the effects of high-intensity interval training (HIIT) and moderate-intensity continuous training (MICT) on functional mobility, muscle strength, and quality of life in diabetic patients is important due to the increasing burden of diabetes and its associated complications. Diabetes often leads to reduced physical function, muscle weakness, and poor quality of life. While both HIIT and MICT have demonstrated positive effects on health outcomes, it is not yet clear which exercise regimen offers superior benefits for improving mobility, strength, and overall well-being in diabetic individuals.
Diabetes often leads to reduced physical function, muscle weakness, and poor quality of life. While both HIIT and MICT have demonstrated positive effects on health outcomes, it is not yet clear which exercise regimen offers superior benefits for improving mobility, strength, and overall well-being in diabetic individuals. Understanding this can guide the development of more effective exercise protocols for diabetes management.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Imran Amjad, Phd.
- Phone Number: 03324390125
- Email: imran.amjad@riphah.edu.pk
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria
:• Adults aging form 35 to 65.
- Both male and female diabetic patients.
- Individuals diagnosed with type 2 diabetes for at least five years.
- Individuals able to participate in moderate to intense physical activity.
Exclusion Criteria:
• Individuals with significant orthopedic limitations.
- Individuals with uncontrolled cardiovascular disease or musculoskeletal issues.
- Individuals with incontinence issues during physical activity or inability to comply to study protocols
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: High Intensity Interval Training
Warm-up: - 5 minutes of dynamic stretching.Exercise Intervals- 4 sets of 4 minutes high-intensity exercises (i.e, sprint intervals on a treadmill and squat jumping) - Intensity: Corresponding to perceived exertion rating (RPE) of 15-18 on the Borg 6-20 scale (32).Cool-down:- 3 minutes of active recovery intervals- Intensity: Rating of perceived exertion (RPE) 8 to 10.Schedule:- Frequency: 3 times per week- Duration: 12-week period- Total session duration: 30-32 minutesObjective:- Focus on maximizing cardiovascular and muscular adaptations through brief, intense activity bursts.
|
3 session per week, 12 weeks sessions continued, each session had 4 sets of 4 minutes exercise with 3 min active rest inbetween routines.
total 30 minutes per session, Sprinting and Jump squatting RPE 15-18
|
|
Active Comparator: Moderate Intensity Continuous Training
Warm-up:- 5 minutes of dynamic stretching.Continuous Exercise:- 40 minutes of moderate-intensity exercises (i.e., brisk walking on a treadmill) - Intensity: Perceived exertion rate of 11-13 on the Borg 6-20 scale (34).Cool-down: None (continuous without intervals)Schedule:- Frequency: 3 times per week- Duration: 12-week period- Total session duration: 45 minutesObjective:- Promote endurance and quality of life with a sustainable approach to improving overall physical endurance. |
3 session per week, 12 weeks sessions continued, 40 minutes one single exercise regime with no intervals.
Brisk Walking on Treadmill, RPE-11-13
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
TUG timed up go test
Time Frame: baseline pre exam, 6th week of intervention, and 12th week
|
Functional mobility is evaluated by the TUG test.
The TUG test has revealed very high test-retest reliability among patients with diabetes, as shown by the ICC values from 0.93 to 0.99
|
baseline pre exam, 6th week of intervention, and 12th week
|
|
Hand Grip Strength Test
Time Frame: baseline pre exam, 6th week of intervention, and 12th week
|
To assess the power of muscles a dynamometer used to test the gripping power of participants making an objective estimate of the strength of the muscles in the upper body.
This method had the same validity as that of the whole functional capacity in diabetic populations, with coefficients of 0.70 to 0.85 being most common
|
baseline pre exam, 6th week of intervention, and 12th week
|
|
Chair Stand Test
Time Frame: baseline pre exam, 6th week of intervention, and 12th week
|
In order to evaluate again the strength of the lower limb muscles.
The individuals were measured how fast they could stand up from a chair and sit down again and again, which is an indicator of muscle endurance and functional strength.
The test has shown really high reliability in diabetic populations with ICC values being around 0.85 to 0.91.
|
baseline pre exam, 6th week of intervention, and 12th week
|
|
The Borg 6-20 Scale
Time Frame: baseline pre exam, 6th week of intervention, and 12th week
|
The Borg 6-20 scale used to measure the rate of perceived exertion.
It has a strong relationship with heart rate and oxygen consumption with the range of correlation coefficients between 0.80 and 0.88 for diabetic individuals.
The Borg RPE scale in T2DM has a test-retest reliability indicated by the Intraclass Correlation Coefficient (ICC) of about 0.85 to 0.92, which means that people give similar ratings of their exertion consistently across repeated sessions in similar exercise conditions
|
baseline pre exam, 6th week of intervention, and 12th week
|
|
WHOQOL-BREF Questionnaire
Time Frame: baseline pre exam, 6th week of intervention, and 12th week
|
The WHOQOL-BREF is a universal instrument that measures the quality of life in different aspects such as physical health, psychological health, social relationships, and environment.
In patients with diabetes, the WHOQOL-BREF reveals a strong internal consistency with Cronbach's alpha values ranging from 0.76 to 0.88
|
baseline pre exam, 6th week of intervention, and 12th week
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sobia Kanwal, tDPT, Riphah International University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR & AHS/24/02110
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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