Intensive Aerobic and Resistance Exercise Program (IAREP)

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).

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus; Cognitive Impairment; Cognitive Dysfunction; Non-insulin-dependent Diabetes Mellitus
• Intervention / Treatment: Other: Intensive Aerobic and Resistance Exercise Program (IAREP)

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 Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore
    • Singapore, Singapore, Singapore, 609788
      • National University Polyclinic (Jurong Polyclinics)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; 12-week Intensive Aerobic and Resistance Exercise Program (IAREP) intervention group	Other: 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.
No Intervention: Control Group; Subjects that receive their usual care in Jurong polyclinic.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: National University of Singapore
• Collaborators: National University Polyclinics, Singapore
• Investigators: Principal Investigator: Vivien Xi Wu, PhD, Alice Lee Centre for Nursing Studies, National University of Singapore

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2023
• Primary Completion (Actual): March 31, 2025
• Study Completion (Actual): March 31, 2025

Study Registration Dates

• First Submitted: April 27, 2024
• First Submitted That Met QC Criteria: May 4, 2024
• First Posted (Actual): May 7, 2024

Study Record Updates

• Last Update Posted (Actual): February 19, 2026
• Last Update Submitted That Met QC Criteria: February 1, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: dementia; rehabilitation; obesity; neurology; T2DM; circuit-based exercise
• Additional Relevant MeSH Terms: Endocrine System Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Nutrition Disorders; Metabolic Diseases; Overnutrition; Body Weight; Neurocognitive Disorders; Glucose Metabolism Disorders; Diabetes Mellitus; Cognition Disorders; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Cognitive Dysfunction; Diabetes Mellitus, Type 2; Dementia
• Other Study ID Numbers: DSRB-2022/00594

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No