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Type2diabetesNCT07416799

Feasibility and Adherence to a Technology-assisted Home-based Strength Training Program in Adults With Type 2 Diabetes Mellitus and Mild Cognitive Impairment

A study testing Progressive Exercise Program (12 Weeks) in people with Type2diabetes and Mild Cognitive Impairment, run by The University of Texas Medical Branch, Galveston at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This is a single-arm feasibility study employing a pre-post design with a 12-week intervention period. The study utilizes a telehealth-assisted home-based resistance exercise program, with a structured progression from supervised to unsupervised sessions over 12 weeks. Read more about this study

Who is it for?
Ages 55 to 80 years
What is being tested?
Progressive Exercise Program (12 Weeks)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
14 Apr 2026to Mar 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age: 55-80 years
  • Diabetes: Diagnosed T2DM with ≥5 years duration
  • Cognitive Status: Mild cognitive impairment as defined by Petersen criteria and confirmed by Montreal Cognitive Assessment (MoCA) scores of 18-25
  • Medication Stability: Stable medication regimen for at least 3 months
  • Physical Capability: Physically capable of participating in moderate-intensity exercise (physician clearance required)
  • Support System: Having a caregiver or support person willing to assist with technology use if needed

Who cannot join

  • Diagnosis of movement disorders such as multiple sclerosis, parkinson's disease
  • Diagnosis of Alzheimer's disease,
  • Current diagnosis of severe depression, major psychiatric conditions such as bipolar disorder, psychosis, schizophrenia, or alcoholism that could affect the ability to understand and/or cooperate fully with the protocol.
  • Significant cerebral vascular disease
  • Concomitant medications with significant cholinergic or anticholinergic effects or adverse effects on cognition, including antipsychotics, tricyclic antidepressants, anticonvulsants, sedative/hypnotics, anxiolytics, glucocorticoids (chronic or frequent intermittent),
  • Visual/hearing impairment that would significantly impact the ability to participate in psychometric testing.
Show all 14Show fewer
  • Significant medical illness or organ failure, including hepatic or renal failure, unstable cardiac disease,
  • Untreated B12 deficiency or hypothyroidism (stable treatment for at least 3 months is allowable).
  • Uncontrolled hypertension: over 160 mmHg systolic or 100 mmHg diastolic (stable treatment is allowable).
  • Stage 5 renal impairment (GFR less than 15 or dialysis).
  • Participation in another clinical trial.
  • Prisoners.
  • Exercise Contraindications: Any condition that would make moderate-intensity exercise unsafe such as a history of severe aortic stenosis, poorly controlled hypertension, angina, or syncope.
  • Lack of Support: No available caregiver or support person for technology assistance

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Liza Durgens contact

(409)772-1011

lidurgen@utmb.edu

United States1 site, 1 recruiting

  • University of Texas Medical Branch, Galveston

    Galveston, Texas, 77555-0133

    Mandeep Sandhu, PhD,PT, 409-772-1011, masandhu@utmb.edu

    Recruiting

Other trials in United States

About this study

This is a single-arm feasibility study employing a pre-post design with a 12-week intervention period. The study utilizes a telehealth-assisted home-based resistance exercise program, with a structured progression from supervised to unsupervised sessions over 12 weeks.

Read the detailed description

The prevalence of T2DM and cognitive impairment increases with age, and these conditions often co-occur, creating compounded health challenges. Physical activity has been shown to benefit both glucose control and cognitive function in older adults. However, traditional supervised exercise programs face barriers, including transportation difficulties, scheduling conflicts, and concerns about exercising in group settings, which are particularly relevant for individuals with cognitive impairment.

Telehealth home-based programs offer a promising solution by providing structured guidance while allowing participants to exercise in familiar environments. The combination of initial supervision transitioning to independent practice addresses both safety concerns and the goal of sustainable behavior change.

Objective:

  • Evaluate the feasibility of implementing a 12-week technology-assisted home-based physical activity program
  • Assess adherence rates to the prescribed exercise regimen
  • Examine changes in physical function, cognitive function, and glycemic control
  • Identify barriers and facilitators to program engagement through qualitative interviews
Being tested
Progressive Exercise Program (12 Weeks)
Keywords
Home-Based exercise, Type 2 Diabetes Mellitus (T2DM), Mild cognitive impairment (MCI), Ages 55-80
Medical subject headings
Cognitive Dysfunction, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Progressive Exercise Program (12 Weeks)Other

    12-week exercise program with gradual transition from supervised to independent sessions. Participants complete 50-minute sessions, 3 times/week, including:

    Warm-up (10 min) Resistance training (35 min): upper arm exercises, wall push-ups, biceps curls, side bends, squats, glute bridges, hip abduction Cool-down (5 min)

    Supervision:

    Weeks 1-2: Mostly supervised Weeks 5-8: Mixed Weeks 9-12: Mostly unsupervised with Zoom/Teams support

    Weekly staff check-ins. Week 13: Repeat baseline tests, questionnaires, blood draw, DEXA scan, and structured interview.

Study groups in NCT07416799
Study groupRoleWhat they receive
Exercise ProgramExperimentalParticipants will complete a 12-week progressive exercise program with 50-minute sessions three times per week, including warm-up, resistance training, and cool-down. Supervision transitions from primarily in-person (Weeks 1-2) to mixed (Weeks 5-8) and mostly unsupervised with virtual support (Weeks 9-12). Weekly check-ins are provided, and a final assessment occurs at Week 13.
Receives: Other: Progressive Exercise Program (12 Weeks)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility of Technology-Assisted Home-Based Exercise Program

    Feasibility will be assessed as the proportion of enrolled participants who complete the full 12-week home-based exercise intervention. The completion rate is calculated as the number of participants who complete the intervention divided by the total number of enrolled participants, expressed as a percentage (0% to 100%). A completion rate of ≥80% is considered indicative of acceptable feasibility.

    Measured: Week 13 (end of intervention and final assessment)

  2. Acceptability of Technology-Assisted Home-Based Exercise Program

    Acceptability will be evaluated using exercise adherence, defined as the percentage of prescribed exercise sessions completed during the 12-week intervention period. Adherence will be calculated using data collected from technology monitoring systems and participant self-report logs. Adherence values range from 0% to 100%, with ≥70% adherence considered acceptable.

    Measured: Week 13 (end of intervention and final assessment)

Secondary outcomes (8)

  1. Change in Balance Performance From Baseline to Week 13

    Balance will be assessed using a standardized clinical balance assessment. Balance performance will be recorded according to the scoring method of the assessment tool used. Change will be calculated as the difference between baseline and Week 13 scores. Higher scores indicate better balance performance.

    Measured: Baseline and Week 13

  2. Change in Cognitive Function using Montreal Cognitive Assessment (MoCA)

    Measured using Montreal Cognitive Assessment (MoCA) scores to detect improvements in executive function and memory.

    Measured: Baseline and Week 13

  3. Change in Cognitive Function (PROMIS Cognitive Function)

    Cognitive function will be assessed using the PROMIS® Cognitive Function measure. Scores are reported as T-scores with higher scores indicating better cognitive function. Change is calculated as the difference between baseline and Week 13 T-scores.

    Measured: Baseline and Week 13

  4. Change in Timed Up and Go (TUG) Test Time From Baseline to Week 13

    Functional mobility will be assessed using the Timed Up and Go (TUG) test. Time to complete the task is recorded in seconds, with lower times indicating better functional mobility. Change is calculated as the difference between baseline and Week 13 TUG times.

    Measured: Baseline and Week 13

  5. Change in Glycemic Control

    Assessed by changes in HbA1C levels to evaluate the metabolic impact of the exercise intervention.

    Measured: Baseline and Week 13

  6. Change in Hand Grip Strength From Baseline to Week 13

    Hand grip strength will be measured using a calibrated hand dynamometer. Grip strength is recorded in kilograms (kg). Change in grip strength will be calculated as the difference between baseline and Week 13 measurements. Higher values indicate greater muscle strength and better physical function.

    Measured: Baseline and Week 13

  7. Change in Six-Minute Walk Test Distance From Baseline to Week 13

    Functional exercise capacity will be assessed using the Six-Minute Walk Test. Total distance walked in six minutes is recorded in meters. Change will be calculated as the difference between baseline and Week 13 distance walked. Greater walking distance indicates better physical endurance and functional capacity.

    Measured: Baseline and Week 13

  8. Change in Instrumental Activities of Daily Living (IADL) Score From Baseline to Week 13

    Functional independence will be assessed using an Instrumental Activities of Daily Living (IADL) assessment. Scores are reported according to the instrument scoring system, with higher scores indicating greater functional independence. Change is calculated as the difference between baseline and Week 13 scores.

    Measured: Baseline and Week 13

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Feb 2026
  2. Study start14 Apr 2026
  3. Primary completionMar 2027 (estimated)
  4. Study completionMar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07416799
Sponsor's protocol ID
25-0195
Status last verified
May 2026
First submitted
2 Feb 2026
Last updated
11 May 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Progressive Exercise Program (12 Weeks) in people with Type2diabetes and Mild Cognitive Impairment, run by The University of Texas Medical Branch, Galveston at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Liza Durgens ((409)772-1011, lidurgen@utmb.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of Technology-Assisted Home-Based Exercise Program (time frame: Week 13 (end of intervention and final assessment)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07416799.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.

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