Type 2 Diabetes MellitusNCT06401733
Intensive Aerobic and Resistance Exercise Program (IAREP)
A study testing Intensive Aerobic and Resistance Exercise Program (IAREP) in people with Type 2 Diabetes Mellitus and Cognitive Impairment, run by National University of Singapore at 1 site in Singapore.
Trial summary
A 12-week Intensive Aerobic and Resistance Exercise Program (IAREP) intervention was implemented on high-risk and low-risk subjects with cognitive impairment in type 2 Diabetes Mellitus. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Type 2 Diabetes Mellitus, Cognitive Impairment, Non-insulin-dependent Diabetes Mellitus
- What is being tested?
- Intensive Aerobic and Resistance Exercise Program (IAREP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteSingapore
- Study dates
- 21 Jul 2023to 31 Mar 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 40 to 85
- Living in the community
- Diagnosed with type 2 diabetes mellitus (T2DM)
- Literate in English or Mandarin
- Activities of daily living (ADL)-independent
- Obtain at least a score of 5 in short physical performance battery (SPPB) test
Who cannot join
- Severe cognitive (e.g., dementia) or psychiatric disorders (e.g., schizophrenia or severe depression)
- Severe hearing or vision impairments
- Terminally ill medical conditions (e.g., end stage cancer), severe cardiovascular, respiratory (e.g., respiratory failure), or orthopedic conditions (e.g., freeze shoulder)
- Absolute contraindications to aerobic exercise and resistance training programs (e.g., recent myocardial infarction or electrocardiography changes, complete heart block, acute congestive heart failure, unstable angina, uncontrolled hypertension)
- Pregnant or breastfeeding women
- Uncomfortable with video-recording of intervention sessions
Trial locations and contacts
1 site in 1 country.
Singapore1 site
National University Polyclinic (Jurong Polyclinics)
Singapore, Singapore, 609788
About this study
Official title: Metabolic, Inflammatory, Cognitive Risk Stratification, and Intensive Aerobic and Resistance Exercise Intervention for Middle-aged and Older Adults With Type 2 Diabetes Mellitus
A 12-week Intensive Aerobic and Resistance Exercise Program (IAREP) intervention was implemented on high-risk and low-risk subjects with cognitive impairment in type 2 Diabetes Mellitus. The study aims to evaluate the effectiveness of IAREP on cognition, metabolic and inflammatory health, physical function, vascular health, and health practice behaviour in the Type 2 Diabetes Mellitus population (T2DM).
Read the detailed description
Background and Significance: T2DM is a leading cause of morbidity and mortality among adults worldwide, with approximately 5 million diabetes-related deaths accounting for 12.8% of all-cause mortality in 2015. The prevalence of T2DM in Asia is on the rise, with an anticipated increase from 78 million in 2015 to 140 million by 2040. Asia, therefore, is emerging as the "diabetes epicentre" due to rapid economic development, urbanisation, and nutrition transition. T2DM is a complex disease with environmental and genetic contributions that cause many severe complications in middle-aged and older adults, including a higher susceptibility to mild cognitive impairment (MCI) and dementia. The prevalence of cognitive impairment in T2DM ranges from 21.8% to 67.5% worldwide in all adults. Our previous study developed a risk stratification score (RSS) to quickly screen the T2DM population for high-risk or low-risk cognitive impairment. Exercise intervention plays a crucial role inof T2DM the management . Aerobic exercise has multiple benefits to metabolic functions, including increasing cardiovascular fitness, improving skeletal muscle capillary density, and reducing body fat. Resistance training is considered a promising intervention for reversing the loss of muscle function and deterioration of muscle structure associated with ageing. Intervention strategies, such as the proposed combined aerobic and resistance training program, will provide a guideline to prescribe exercise dosage for individuals with T2DM who are at risk of cognitive impairment.
Methods: A mixed-methods study was conducted, comprising a quasi-experimental control trial followed by a process evaluation through focus group discussions. The study screened 150 subjects, and 58 were recruited. Participants were assigned to either the exercise intervention group or the non-exercise control group according to their availability. The intervention group received a 12-week Intensive Aerobic and Resistance Exercise Program (IAREP), while the control group received usual care from Jurong National University Polyclinics without participating in the IAREP exercise.
- Conditions
- Type 2 Diabetes Mellitus, Cognitive Impairment, Non-insulin-dependent Diabetes Mellitus, Cognitive Dysfunction
- Being tested
- Intensive Aerobic and Resistance Exercise Program (IAREP)
- Keywords
- T2DM, circuit-based exercise, neurology, dementia, obesity, rehabilitation
- Medical subject headings
- Diabetes Mellitus, Type 2, Cognitive Dysfunction, Dementia, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive Aerobic and Resistance Exercise Program (IAREP)Other
IAREP is a combined aerobic exercise and resistance training program that developed by qualified exercise professionals. It encompasses a 12-week exercise intervention, conducted in a blended mode which consists of face-to-face exercise, Zoom exercise, and pre-recorded video exercise.
Frequency: 3 times exercise per week. Intensity: moderate to vigorous exercise. Time of the exercise: 45-60 mins. Type of exercise: combined aerobic and resistance training.
Warm-up: aerobic workout with dynamic stretch (for targeted muscles). Aerobic exercise: each session encompasses 5 exercise. Resistance training: each session encompasses 4 exercise, 2 upper body exercise and 2 lower body exercise.
Cool-down: relax targeted muscles.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 12-week Intensive Aerobic and Resistance Exercise Program (IAREP) intervention group Receives: Other: Intensive Aerobic and Resistance Exercise Program (IAREP) |
| Control Group | No intervention | Subjects that receive their usual care in Jurong polyclinic. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cognitive Function Based on Risk Stratification Score (RSS)
Pre- and post-intervention measurements were conducted to assess the Risk Stratification Score (RSS).
RSS scores range from -3.4 to 6.8; higher scores represent worse outcomes.
Measured: Baseline and 12 weeks
Number of Participants With Change in Cognitive Function (Cognitive Impairment) Based on Vascular Dementia Battery (VDB)
Pre- and post-intervention measurements were conducted to assess the number of participants with change in cognitive function (Cognitive Impairment). This outcome reports the count of participants with Cognitive Impairment (CI) in each group at both assessments. A decrease in this count from Pre to Post indicates improved group cognitive function; an increase indicates worsened function.
CI was diagnosed per Vascular Dementia Battery (VDB) criteria as a score below the clinical cutoff in any of its seven domains: executive function (score range 0-18), attention (score range 0-60), language (score range 0-15), verbal memory (score range 0-110), visual memory (score range 0-117), visuoconstruction (score range 0-97), and visuomotor speed (score range 0-150), where a higher score means a better outcome.
Measured: Baseline and 12 weeks
Change in Cognitive Function Based on the Montreal Cognitive Assessment (MoCA)
Pre- and post-intervention measurements were conducted to assess the Montreal Cognitive Assessment (MoCA).
MoCA scores range from 0 to 30, with higher scores indicating better outcomes.
Measured: Baseline and 12 weeks
Secondary outcomes (8)
Change in Metabolic Health
Pre- and post-intervention measurements were conducted. Measure the change in blood test of HbA1c for metabolic conditions.
Measured: Baseline and 12 weeks
Change in Inflammatory Condition
Pre- and post-intervention measurements were conducted. Measure the change in blood tests of IL6, CRP, and TNFa for inflammatory conditions.
Measured: Baseline and 12 weeks
Change in Short Physical Performance Battery (SPPB)
Pre- and post-intervention measurements were conducted. Measure the change in Short Physical Performance Battery (SPPB). The scores range from 0 to 12; a higher score means a better outcome.
Measured: Baseline and 12 weeks
Change in Sarcopenia Risk
Pre- and post-intervention measurements were conducted. Measure the change in sarcopenia condition from a rapid sarcopenia screening of Strength, Assistance with walking, Rise from a chair, Climb stairs and Falls (SARC-F). The scores range from 0 to 10; a higher score means a worse outcome.
Measured: Baseline and 12 weeks
Change in Blood Pressure
Pre- and post-intervention measurements were conducted. Measure the change in systolic blood pressure (SBP) and diastolic blood pressure.
Measured: Baseline and 12 weeks
Change in Physical Activity: International Physical Activity Questionnaire - Short Form
The IPAQ-SF questionnaire assesses daily physical activities by asking individuals about their engagement in vigorous activities (e.g., heavy lifting), moderate activities (e.g., carrying light loads), and walking over the past 7 days. The IPAQ-SF provides valuable insights into physical activity levels, aiding in health risk assessments and lifestyle improvements.
Measured: Baseline and 12 weeks
Change in Self-care of Diabetes Index (SCODI)
Pre- and post-intervention measurements were conducted. Measure the change in the Self-care of Diabetes Inventory. There are 40 items (5-point Likert type) and 4 dimensions: self-care maintenance, self-care monitoring, self-care management and self-care confidence.
Measured: Baseline and 12 weeks
Change in Self-related and Health Practice (SRAHP)
Pre- and post-intervention measurements were conducted. Measure the change in self-perceived ability to implement health-promoting behaviours, which include subscales of Exercise, Nutrition, Responsible Health Practice, and Psychological Well-being. The scores range from 0 to 112; a higher score means a better outcome.
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2024
- Study start21 Jul 2023
- Primary completion31 Mar 2025
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies 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
- Non-randomised
- Intervention model
- Sequential
- Model description
- The study consists of two phases. Phase 1 is a cross-sectional study conducted to gather baseline data and identify eligible participants. Phase 2 involves recruiting participants from the pool established in Phase 1 for the IAREP intervention phase. This sequential design allows Phase 1 findings to inform participant selection and eligibility for Phase 2, facilitating a targeted approach to the intervention.
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- National University Polyclinics, Singapore
- Responsible party
- Principal investigator, Vivien Xi WU, PhD, National University of Singapore
- Investigators
- Vivien Xi Wu, PhD, Principal investigator, Alice Lee Centre for Nursing Studies, National University of Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06401733
- Sponsor's protocol ID
- DSRB-2022/00594
- Status last verified
- Feb 2026
- First submitted
- 27 Apr 2024
- Last updated
- 19 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang J, Tam WWS, Lu J, Chen J, Montayre J, Kusuyama J, Dong Y, Yap XY, Zhou W, Wang N, Yeo HN, Lee FJS, Wu VX. A technology-blended exercise intervention for cognitive risk reduction and brain health in middle-aged and older adults with type 2 diabetes in Singapore: a mixed-methods study. J Gerontol A Biol Sci Med Sci. 2026 Aug 4;81(9):glag192. doi: 10.1093/gerona/glag192.
PubMed 42550210
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic, Inflammatory, Cognitive Risk Stratification, and Intensive Aerobic and Resistance Exercise Intervention for Middle-aged and Older Adults With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT06401733
- Acronym / sponsor ID
- DSRB-2022/00594
- Conditions
- Type 2 Diabetes Mellitus, Cognitive Impairment, Non-insulin-dependent Diabetes Mellitus, Cognitive Dysfunction
- Keywords
- T2DM, circuit-based exercise, neurology, dementia, obesity, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- National University of SingaporeUniversity, hospital or other
- Collaborators
- National University Polyclinics, Singapore
- Study start
- 21 Jul 2023 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 7 May 2024 (actual)
- Results
- Posted 19 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A 12-week Intensive Aerobic and Resistance Exercise Program (IAREP) intervention was implemented on high-risk and low-risk subjects with cognitive impairment in type 2 Diabetes Mellitus. The study aims to evaluate the effectiveness of IAREP on cognition, metabolic and inflammatory health, physical function, vascular health, and health practice behaviour in the Type 2 Diabetes Mellitus population (T2DM).
Detailed description
Background and Significance: T2DM is a leading cause of morbidity and mortality among adults worldwide, with approximately 5 million diabetes-related deaths accounting for 12.8% of all-cause mortality in 2015. The prevalence of T2DM in Asia is on the rise, with an anticipated increase from 78 million in 2015 to 140 million by 2040. Asia, therefore, is emerging as the "diabetes epicentre" due to rapid economic development, urbanisation, and nutrition transition. T2DM is a complex disease with environmental and genetic contributions that cause many severe complications in middle-aged and older adults, including a higher susceptibility to mild cognitive impairment (MCI) and dementia. The prevalence of cognitive impairment in T2DM ranges from 21.8% to 67.5% worldwide in all adults. Our previous study developed a risk stratification score (RSS) to quickly screen the T2DM population for high-risk or low-risk cognitive impairment. Exercise intervention plays a crucial role inof T2DM the management . Aerobic exercise has multiple benefits to metabolic functions, including increasing cardiovascular fitness, improving skeletal muscle capillary density, and reducing body fat. Resistance training is considered a promising intervention for reversing the loss of muscle function and deterioration of muscle structure associated with ageing. Intervention strategies, such as the proposed combined aerobic and resistance training program, will provide a guideline to prescribe exercise dosage for individuals with T2DM who are at risk of cognitive impairment.
Methods: A mixed-methods study was conducted, comprising a quasi-experimental control trial followed by a process evaluation through focus group discussions. The study screened 150 subjects, and 58 were recruited. Participants were assigned to either the exercise intervention group or the non-exercise control group according to their availability. The intervention group received a 12-week Intensive Aerobic and Resistance Exercise Program (IAREP), while the control group received usual care from Jurong National University Polyclinics without participating in the IAREP exercise.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study consists of two phases. Phase 1 is a cross-sectional study conducted to gather baseline data and identify eligible participants. Phase 2 involves recruiting participants from the pool established in Phase 1 for the IAREP intervention phase. This sequential design allows Phase 1 findings to inform participant selection and eligibility for Phase 2, facilitating a targeted approach to the intervention.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Intensive Aerobic and Resistance Exercise Program (IAREP)12-week Intensive Aerobic and Resistance Exercise Program (IAREP) intervention group |
| Control Group | No intervention | –Subjects that receive their usual care in Jurong polyclinic. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 40 to 85
- Living in the community
- Diagnosed with type 2 diabetes mellitus (T2DM)
- Literate in English or Mandarin
- Activities of daily living (ADL)-independent
Key exclusion criteria (6 listed)
- Severe cognitive (e.g., dementia) or psychiatric disorders (e.g., schizophrenia or severe depression)
- Severe hearing or vision impairments
- Terminally ill medical conditions (e.g., end stage cancer), severe cardiovascular, respiratory (e.g., respiratory failure), or orthopedic conditions (e.g., freeze shoulder)
- Absolute contraindications to aerobic exercise and resistance training programs (e.g., recent myocardial infarction or electrocardiography changes, complete heart block, acute congestive heart failure, unstable angina, uncontrolled hypertension)
- Pregnant or breastfeeding women
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 |
|---|---|---|
| Intensive Aerobic and Resistance Exercise Program (IAREP)IAREP is a combined aerobic exercise and resistance training program that developed by qualified exercise professionals. It encompasses a 12-week exercise intervention, conducted in a blended mode which consists of face-to-face exercise, Zoom exercise, and pre-recorded video exercise. Frequency: 3 times exercise per week. Intensity: moderate to vigorous exercise. Time of the exercise: 45-60 mins. Type of exercise: combined aerobic and resistance training. Warm-up: aerobic workout with dynamic stretch (for targeted muscles). Aerobic exercise: each session encompasses 5 exercise. Resistance training: each session encompasses 4 exercise, 2 upper body exercise and 2 lower body exercise. Cool-down: relax targeted muscles. | Other | Intervention Group |
Primary outcome
Change in Cognitive Function Based on Risk Stratification Score (RSS)
Time frame: Baseline and 12 weeks
Pre- and post-intervention measurements were conducted to assess the Risk Stratification Score (RSS). RSS scores range from -3.4 to 6.8; higher scores represent worse outcomes.
Number of Participants With Change in Cognitive Function (Cognitive Impairment) Based on Vascular Dementia Battery (VDB)
Time frame: Baseline and 12 weeks
Pre- and post-intervention measurements were conducted to assess the number of participants with change in cognitive function (Cognitive Impairment). This outcome reports the count of participants with Cognitive Impairment (CI) in each group at both assessments. A decrease in this count from Pre to Post indicates improved group cognitive function; an increase indicates worsened function. CI was diagnosed per Vascular Dementia Battery (VDB) criteria as a score below the clinical cutoff in any of its seven domains: executive function (score range 0-18), attention (score range 0-60), language (score range 0-15), verbal memory (score range 0-110), visual memory (score range 0-117), visuoconstruction (score range 0-97), and visuomotor speed (score range 0-150), where a higher score means a better outcome.
Change in Cognitive Function Based on the Montreal Cognitive Assessment (MoCA)
Time frame: Baseline and 12 weeks
Pre- and post-intervention measurements were conducted to assess the Montreal Cognitive Assessment (MoCA). MoCA scores range from 0 to 30, with higher scores indicating better outcomes.
8 secondary outcomes
Change in Metabolic Health
Time frame: Baseline and 12 weeks
Change in Inflammatory Condition
Time frame: Baseline and 12 weeks
Change in Short Physical Performance Battery (SPPB)
Time frame: Baseline and 12 weeks
Change in Sarcopenia Risk
Time frame: Baseline and 12 weeks
Change in Blood Pressure
Time frame: Baseline and 12 weeks
Change in Physical Activity: International Physical Activity Questionnaire - Short Form
Time frame: Baseline and 12 weeks
Change in Self-care of Diabetes Index (SCODI)
Time frame: Baseline and 12 weeks
Change in Self-related and Health Practice (SRAHP)
Time frame: Baseline and 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42550210Zhang J, Tam WWS, Lu J, Chen J, Montayre J, Kusuyama J, Dong Y, Yap XY, Zhou W, Wang N, Yeo HN, Lee FJS, Wu VX. A technology-blended exercise intervention for cognitive risk reduction and brain health in middle-aged and older adults with type 2 diabetes in Singapore: a mixed-methods study. J Gerontol A Biol Sci Med Sci. 2026 Aug 4;81(9):glag192. doi: 10.1093/gerona/glag192.
- 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.
Vivien Xi Wu, PhD principal investigator
Alice Lee Centre for Nursing Studies, National University of Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive Aerobic and Resistance Exercise Program (IAREP) in people with Type 2 Diabetes Mellitus and Cognitive Impairment, run by National University of Singapore at 1 site in Singapore.
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 6 inclusion and 6 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: finished, as of the sponsor's last update on 19 Feb 2026. 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 Singapore. 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?
Yes. Results are posted in the registry (first posted 19 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cognitive Function Based on Risk Stratification Score (RSS) (time frame: Baseline and 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06401733, which also lists 1 linked publication.
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 19 Feb 2026.