20 Participants NeededMy employer runs this trial

Exercise Program for Diabetes and Mild Cognitive Impairment

LD
Overseen ByLiza Durgens
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a 12-week home-based exercise program, called the Progressive Exercise Program, can assist individuals with both diabetes and mild memory problems. Participants will engage in 50-minute exercise sessions three times a week, beginning with supervision and gradually transitioning to self-guided workouts with virtual support. The trial aims to determine if this program is feasible and beneficial for managing these conditions. Individuals who have had type 2 diabetes for at least five years, experience mild memory issues, and can safely perform moderate exercise may be suitable candidates for this study. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance the quality of life for those facing similar health challenges.

Will I have to stop taking my current medications?

The trial requires that your medication regimen be stable for at least 3 months before participating, so you should not need to stop taking your current medications if they have been stable. However, certain medications with significant effects on cognition are not allowed.

What prior data suggests that this exercise program is safe for participants with diabetes and mild cognitive impairment?

Studies have shown that progressive exercise programs are generally safe and manageable for participants. Research indicates that these routines, which include aerobic activities (such as walking or cycling) and resistance training (exercises that build muscle strength), can enhance brain function and overall health in people with type 2 diabetes.

For example, one study found that after six months of regular progressive exercise, participants with type 2 diabetes improved in overall thinking abilities and specific mental skills. This finding suggests that the exercise was effective and safe, without causing significant negative side effects.

Another study highlighted that moderate exercise intensity, a component of these programs, can significantly benefit both metabolism and brain health, further supporting the safety and advantages of such routines.

Overall, the evidence suggests that a structured exercise program like the one in this study is a safe option for improving health, especially for those managing diabetes and mild cognitive issues.12345

Why are researchers excited about this trial?

Unlike most treatments for diabetes and mild cognitive impairment, which often rely on medication or dietary changes, this progressive exercise program offers a physical activity-based approach. The unique feature of this program is its structured transition from in-person guidance to virtual support, promoting independence and long-term lifestyle changes. Researchers are excited because this method could enhance both physical health and cognitive function with minimal reliance on drugs, offering a holistic alternative that empowers patients to take control of their health.

What evidence suggests that this exercise program is effective for diabetes and mild cognitive impairment?

Research has shown that exercise can greatly improve brain function in people with type 2 diabetes (T2DM). A review of multiple studies found that 81.8% reported positive effects of exercise on the brain in T2DM patients. One study discovered that a 6-month strength-training program enhanced overall thinking skills and decision-making abilities. In people with mild cognitive impairment (MCI), exercise improved focus, memory, and planning skills. This trial will evaluate a 12-week progressive exercise program to determine if it can boost mental abilities in those with diabetes and MCI.25678

Who Is on the Research Team?

MS

Mandeep Sandhu, PhD, PT

Principal Investigator

University of Texas Medial Branch

Are You a Good Fit for This Trial?

This trial is for adults aged 55-80 who have had type 2 diabetes for at least 5 years and mild memory or thinking problems. Participants must be physically able to exercise, on stable medications, and have a caregiver or support person to help with technology if needed.

Inclusion Criteria

4. Medication Stability: Stable medication regimen for at least 3 months
I have had type 2 diabetes for at least 5 years.
3. Cognitive Status: Mild cognitive impairment as defined by Petersen criteria and confirmed by Montreal Cognitive Assessment (MoCA) scores of 18-25
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants complete a 12-week progressive exercise program with 50-minute sessions three times per week, transitioning from supervised to unsupervised sessions

12 weeks
Weekly check-ins, final assessment at Week 13

Follow-up

Participants are monitored for changes in physical function, cognitive function, and glycemic control

1 week
Final assessment at Week 13

What Are the Treatments Tested in This Trial?

Interventions

  • Progressive Exercise Program

Trial Overview

The study tests whether a home-based strength training program delivered via telehealth over 12 weeks is practical and if people stick with it. The program starts with supervised sessions that gradually become unsupervised.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Exercise ProgramExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

The University of Texas Medical Branch, Galveston

Lead Sponsor

Trials
263
Recruited
55,400+

Citations

Meta-analysis of the effect of exercise intervention on ... - PMC

The results showed that exercise intervention could improve the cognitive function of elderly patients with T2DM, with a statistically ...

The Impact of Exercise Training on the Brain and Cognition in ...

18 out of 22 papers (81.8%) showed a significant positive effect of exercise training on cognition in T2DM, of which two studies only showed ...

Effects of a moderate combined exercise program on ...

Exercises were beneficial to enhancing cognition in the T2DM population; however, because of the heterogeneity of the instruments and the small number of ...

Progress on exercise therapy in type 2 diabetes mellitus ...

Clinical studies indicate that the earliest manifestations of cognitive impairment in T2DM patients are reduced information processing speed and executive ...

Effects of Exercise on Type 2 Diabetes Mellitus-Related ...

Improvements in global and executive cognitive function have been found after a 6-month progressive resistance-training program compared to a ...

Effect of Exercise on the Cognitive Function of Older Patients ...

One study found that 6 months of progressive aerobic and resistance training improved global and domain-specific cognitive function in patients with T2DM ( ...

Exercise Program for Diabetes and Mild Cognitive ...

This is a single-arm feasibility study employing a pre-post design with a 12-week intervention period.

The comprehensive impact of exercise interventions on ... - PMC

Evidence suggests that structured, multimodal exercise programs—combining aerobic (≥ 150 min/week), resistance (2–3 times/week), and balance ...