Type 2 Diabetes Mellitus With ComplicationNCT07484399
Comparing Effects of HIIT and MICT on Functional Mobility, Muscle Strength, and Quality of Life in Diabetic Patients
A study testing High Intensity Interval Training and Moderate Intensity Continuous Training in people with Type 2 Diabetes Mellitus With Complication, run by Riphah International University.
Trial summary
To compare the effects of High-Intensity Interval Training (HIIT) and Moderate-Intensity Continuous Training (MICT) on functional mobility, muscle strength, and quality of life in individuals with type-2-diabetes. Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Type 2 Diabetes Mellitus With Complication
- What is being tested?
- High Intensity Interval Training and Moderate Intensity Continuous Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- 5 Mar 2026to 22 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- :• 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.
Who cannot join
- • 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
To compare the effects of High-Intensity Interval Training (HIIT) and Moderate-Intensity Continuous Training (MICT) on functional mobility, muscle strength, and quality of life in individuals with type-2-diabetes.
Read the 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.
- Being tested
- High Intensity Interval Training, Moderate Intensity Continuous Training
- Keywords
- muscles weakness, disability, reduced quality of life,
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Intensity Interval TrainingOther
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
Moderate Intensity Continuous TrainingOther
3 session per week, 12 weeks sessions continued, 40 minutes one single exercise regime with no intervals. Brisk Walking on Treadmill, RPE-11-13
| Study group | Role | What they receive |
|---|---|---|
| High Intensity Interval Training | Active comparator | 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. Receives: Other: High Intensity Interval Training |
| Moderate Intensity Continuous Training | Active comparator | 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. Receives: Other: Moderate Intensity Continuous Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
TUG timed up go test
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
Measured: baseline pre exam, 6th week of intervention, and 12th week
Hand Grip Strength Test
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
Measured: baseline pre exam, 6th week of intervention, and 12th week
Chair Stand Test
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.
Measured: baseline pre exam, 6th week of intervention, and 12th week
The Borg 6-20 Scale
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
Measured: baseline pre exam, 6th week of intervention, and 12th week
WHOQOL-BREF Questionnaire
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
Measured: baseline pre exam, 6th week of intervention, and 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2026
- Study start5 Mar 2026 (estimated)
- Primary completion17 Jul 2026 (estimated)
- Study completion22 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus With ComplicationStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sobia Kanwal, tDPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07484399
- Sponsor's protocol ID
- REC/RCR & AHS/24/02110
- Status last verified
- Mar 2026
- First submitted
- 16 Mar 2026
- Last updated
- 20 Mar 2026
- Results posted
- 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 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07484399
- Acronym / sponsor ID
- REC/RCR & AHS/24/02110
- Keywords
- muscles weakness, disability, reduced quality of life,
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 5 Mar 2026 (estimated)
- Primary completion
- 17 Jul 2026 (estimated)
- Study completion
- 22 Sep 2026 (estimated)
- First posted
- 20 Mar 2026 (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.
To compare the effects of High-Intensity Interval Training (HIIT) and Moderate-Intensity Continuous Training (MICT) on functional mobility, muscle strength, and quality of life in individuals with type-2-diabetes.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Intensity Interval Training | Active comparator | Other: High Intensity Interval TrainingWarm-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. |
| Moderate Intensity Continuous Training | Active comparator | Other: Moderate Intensity Continuous TrainingWarm-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. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- :• 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.
Key exclusion criteria (3 listed)
- • Individuals with significant orthopedic limitations.
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 |
|---|---|---|
| High Intensity Interval Training3 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 | Other | High Intensity Interval Training |
| Moderate Intensity Continuous Training3 session per week, 12 weeks sessions continued, 40 minutes one single exercise regime with no intervals. Brisk Walking on Treadmill, RPE-11-13 | Other | Moderate Intensity Continuous Training |
Primary outcome
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
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
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.
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- 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.
Sobia Kanwal, tDPT principal investigator
Riphah International University
Questions about this trial
What is this clinical trial studying?
A study testing High Intensity Interval Training and Moderate Intensity Continuous Training in people with Type 2 Diabetes Mellitus With Complication, run by Riphah International University.
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 4 inclusion and 3 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: opening soon, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Imran Amjad, Phd. (03324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TUG timed up go test (time frame: baseline pre exam, 6th week of intervention, and 12th week). The study lists 5 primary outcomes in all. 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 20 Mar 2026.