Intensive Aerobic and Resistance Exercise Program (IAREP)

NCT06401733 | Completed Results

• 1 other identifier: DSRB-2022/00594
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Type 2 Diabetes Mellitus; Cognitive Impairment; Non-insulin-dependent Diabetes Mellitus; Cognitive Dysfunction

Keywords

T2DM; circuit-based exercise; neurology; dementia; obesity; rehabilitation

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (8)

• Change in Metabolic Health

  Baseline and 12 weeks

• Change in Inflammatory Condition

  Baseline and 12 weeks

• Change in Short Physical Performance Battery (SPPB)

  Baseline and 12 weeks

• Change in Sarcopenia Risk

  Baseline and 12 weeks

• Change in Blood Pressure

  Baseline and 12 weeks

Study Arms (2)

Intervention Group

EXPERIMENTAL

12-week Intensive Aerobic and Resistance Exercise Program (IAREP) intervention group

Other: Intensive Aerobic and Resistance Exercise Program (IAREP)

Control Group

NO INTERVENTION

Subjects that receive their usual care in Jurong polyclinic.

Interventions

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.

Intervention Group

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National University of Singapore: lead
• National University Polyclinics, Singapore: collaborator

Study Sites (1)

National University Polyclinic (Jurong Polyclinics)

Singapore, Singapore, 609788, Singapore

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Cognitive Dysfunction; Dementia; Obesity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Vivien Xi WU
• Organization: National University of Singapore

vivien.wu@nus.edu.sg

65-66012756

Study Officials

• Vivien Xi Wu, PhD

  Alice Lee Centre for Nursing Studies, National University of Singapore

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: April 27, 2024
• First Posted: May 7, 2024
• Study Start: July 21, 2023
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: February 19, 2026
• Results First Posted: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)