NCT07484399

Brief 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.

Trial Health

65
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Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
5mo left

Started Mar 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress32%
Mar 2026Sep 2026

Study Start

First participant enrolled

March 5, 2026

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

March 16, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 20, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 17, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 22, 2026

Last Updated

March 20, 2026

Status Verified

March 1, 2026

Enrollment Period

4 months

First QC Date

March 16, 2026

Last Update Submit

March 16, 2026

Conditions

Keywords

muscles weakness, disability, reduced quality of life,

Outcome Measures

Primary Outcomes (5)

  • 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

    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

    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.

    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

    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

    baseline pre exam, 6th week of intervention, and 12th week

Study Arms (2)

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.

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.

Other: Moderate Intensity Continuous Training

Interventions

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

High Intensity Interval Training

3 session per week, 12 weeks sessions continued, 40 minutes one single exercise regime with no intervals. Brisk Walking on Treadmill, RPE-11-13

Moderate Intensity Continuous Training

Eligibility Criteria

Age35 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • :• 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

High-Intensity Interval Training

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Sobia Kanwal, tDPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Imran Amjad, Phd.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
It was a single blinded study, the assessor was blind
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2026

First Posted

March 20, 2026

Study Start

March 5, 2026

Primary Completion (Estimated)

July 17, 2026

Study Completion (Estimated)

September 22, 2026

Last Updated

March 20, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share