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Completed

NCT Number: NCT06401733

Intensive Aerobic and Resistance Exercise Program (IAREP)

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).

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Key information

Conditions

Type 2 Diabetes Mellitus Body Weight Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Cognitive Impairment Dementia Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Mental Disorders Metabolic Diseases Nervous System Diseases Neurocognitive Disorders Non-Insulin-Dependent Diabetes Mellitus Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National University Polyclinic (Jurong Polyclinics)

Singapore, 609788

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Change in Metabolic Health

    Time frame: Baseline and 12 weeks

    Pre- and post-intervention measurements were conducted. Measure the change in blood test of HbA1c for metabolic conditions.

  2. Change in Inflammatory Condition

    Time frame: Baseline and 12 weeks

    Pre- and post-intervention measurements were conducted. Measure the change in blood tests of IL6, CRP, and TNFa for inflammatory conditions.

  3. Change in Short Physical Performance Battery (SPPB)

    Time frame: Baseline and 12 weeks

    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.

  4. Change in Sarcopenia Risk

    Time frame: Baseline and 12 weeks

    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.

  5. Change in Blood Pressure

    Time frame: Baseline and 12 weeks

    Pre- and post-intervention measurements were conducted. Measure the change in systolic blood pressure (SBP) and diastolic blood pressure.

  6. Change in Physical Activity: International Physical Activity Questionnaire - Short Form

    Time frame: Baseline and 12 weeks

    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.

  7. Change in Self-care of Diabetes Index (SCODI)

    Time frame: Baseline and 12 weeks

    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.

  8. Change in Self-related and Health Practice (SRAHP)

    Time frame: Baseline and 12 weeks

    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.

Sponsors and collaborators

Lead sponsor

National University of Singapore

Other

Collaborators

  • National University Polyclinics, Singapore

Registry information

Official study title

Metabolic, Inflammatory, Cognitive Risk Stratification, and Intensive Aerobic and Resistance Exercise Intervention for Middle-aged and Older Adults With Type 2 Diabetes Mellitus

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 7, 2024
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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