Clinical trial NCT06401733: Intensive Aerobic and Resistance Exercise Program (IAREP)
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Cognitive Impairment
Non-insulin-dependent Diabetes Mellitus
Cognitive Dysfunction
Keywords: T2DM
circuit-based exercise
neurology
dementia
obesity
rehabilitation
Lead sponsor: National University of Singapore
Sponsor class: OTHER
Collaborators: name: National University Polyclinics, Singapore
First posted: 2024-05-07
Enrollment: 58
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention 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 an 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.
Primary purpose: PREVENTION

Brief summary: A 12-weeks Intensive Aerobic and Resistance Exercise Program (IAREP) intervention will be implemented on high-risk and low-risk of cognitive impairment subjects in type 2 Diabetes Mellitus. The study aim to evaluate the effectiveness of IAREP on cognition, metabolic health, physical health, and psychological health in Type 2 Diabetes Mellitus population.

Detailed description: Purpose: A single-site, non-randomized, prospective clinical trial is proposed to determine the significance of an Intensive Aerobic and Resistance Exercise Program on cognitive function, metabolic health, and inflammatory conditions in individuals with Type 2 diabetes mellitus (T2DM) who present with high-risk and low-risk cognitive impairment.

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 epicenter" due to rapid economic development, urbanization, 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 an important role in T2DM 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 aging. 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 \& Research Plan: The study will recruit 80 subjects, who will be assigned to either the exercise intervention group or the non-exercise control group according to their availability. The intervention group will receive a 12-week Intensive Aerobic and Resistance Exercise Program (IAREP), while the control group will not have IAREP exercise and will continue to receive usual care from Jurong National University Polyclinics. The primary outcomes include cognition, metabolic health, inflammatory conditions, and physical and psychological health.

Eligibility criteria: 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

Primary outcomes:
measure: Change in cognitive function
timeFrame: Baseline and 12 weeks
measure: Change in metabolic health
timeFrame: Baseline and 12 weeks
measure: Change in inflammatory condition
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Psychological well-beings
timeFrame: 12 weeks
measure: Change in Short Physical Performance Battery (SPPB)
timeFrame: Baseline and 12 weeks
measure: Change in Body Mass Index (BMI)
timeFrame: Baseline and 12 weeks
measure: Change in sarcopenia condition
timeFrame: Baseline and 12 weeks
measure: Change in self-care of chronic illness
timeFrame: Baseline and 12 weeks
measure: Change in health practice behaviour
timeFrame: Baseline and 12 weeks
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Polyclinic (Jurong Polyclinics)
Study officials:
affiliation: Alice Lee Centre for Nursing Studies, National University of Singapore
name: Vivien Xi Wu, PhD
role: PRINCIPAL_INVESTIGATOR
References: