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| Name | Class |
|---|---|
| National University Polyclinics, Singapore | OTHER |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | 12-week Intensive Aerobic and Resistance Exercise Program (IAREP) intervention group |
|
| Control Group | No Intervention | Subjects that receive their usual care in Jurong polyclinic. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | Baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Metabolic Health | Pre- and post-intervention measurements were conducted. Measure the change in blood test of HbA1c for metabolic conditions. | Baseline and 12 weeks |
| Change in Inflammatory Condition |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vivien Xi Wu, PhD | Alice Lee Centre for Nursing Studies, National University of Singapore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National University Polyclinic (Jurong Polyclinics) | Singapore | Singapore | 609788 | Singapore |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Group | 12-week Intensive Aerobic and Resistance Exercise Program (IAREP) intervention group 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. |
| FG001 | Control Group | Subjects that receive their usual care in Jurong polyclinic. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Group | 12-week Intensive Aerobic and Resistance Exercise Program (IAREP) intervention group 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Middle-aged is considered when aged equals or more than 40, and equal or less than 60. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Both intervention and control groups. Post-intervention of RSS scores (cutoff score of 0.3), those higher than 0.3 have a higher risk of cognitive impairment. The lower the score, the lower the risk of cognitive impairment. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline and 12 weeks |
|
12 Weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | Subjects that received a 12-week Intensive Aerobic and Resistance Exercise Program (IAREP) intervention group. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Vivien Xi WU | National University of Singapore | 65-66012756 | vivien.wu@nus.edu.sg |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 29, 2023 | Apr 30, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D060825 | Cognitive Dysfunction |
| D003704 | Dementia |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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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.
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|
Pre- and post-intervention measurements were conducted. Measure the change in blood tests of IL6, CRP, and TNFa for inflammatory conditions.
| 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. | 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. | 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. | 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. | 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. | 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. | Baseline and 12 weeks |
| BG001 | Control Group | Subjects that receive their usual care in Jurong polyclinic. |
| BG002 | Total | Total of all reporting groups |
| Number |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race/Ethnicity, Customized | The ethnicity in both the intervention and control groups. | Number | participants |
|
|
|
| Secondary | Change in Metabolic Health | Pre- and post-intervention measurements were conducted. Measure the change in blood test of HbA1c for metabolic conditions. | Not Posted | Jan 2030 | Baseline and 12 weeks | Participants |
| Secondary | 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. | Not Posted | Jan 2030 | Baseline and 12 weeks | Participants |
| Secondary | 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. | Not Posted | Jan 2030 | Baseline and 12 weeks | Participants |
| Secondary | 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. | Not Posted | Jan 2030 | Baseline and 12 weeks | Participants |
| Secondary | Change in Blood Pressure | Pre- and post-intervention measurements were conducted. Measure the change in systolic blood pressure (SBP) and diastolic blood pressure. | Not Posted | Jan 2030 | Baseline and 12 weeks | Participants |
| Secondary | 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. | Not Posted | Jan 2030 | Baseline and 12 weeks | Participants |
| Secondary | 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. | Not Posted | Jan 2030 | Baseline and 12 weeks | Participants |
| Secondary | 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. | Not Posted | Jan 2030 | Baseline and 12 weeks | Participants |
| Primary | 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. | Both intervention and control groups. | Posted | Count of Participants | Participants | Baseline and 12 weeks |
|
|
|
| Primary | 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. | Both intervention and control groups. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline and 12 weeks |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | Control | Subjects that received their usual care in Jurong polyclinic. | 0 | 28 | 0 | 28 | 0 | 28 |
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| D004700 | Endocrine System Diseases |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |