High-Intensity + Home Exercise for Cognitive Impairment

(HEALTH-COG Trial)

Recruiting at 2 trial locations

Overseen By Pariya Wheeler, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Must be taking: ART regimen

Must not be taking: Insulin

Disqualifiers: Uncontrolled hypertension, Diabetes, Anemia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

Duration: 16 weeks

110 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you must be on a stable ART regimen for at least 12 months, and any hormone therapy must be stable for more than 3 months.

What data supports the effectiveness of the treatment High-Intensity + Home Exercise for Cognitive Impairment?

Research shows that home-based exercise programs, like those using smartphones or voice-controlled assistants, can improve physical fitness and patient satisfaction. Additionally, high-intensity exercise has been shown to enhance exercise capacity and improve heart health, which may indirectly support cognitive function. ^{1 2 3 4 5}

Is high-intensity exercise safe for people with cognitive impairment?

High-intensity interval training (HIIT) has been shown to be generally safe for people with cardiovascular diseases and stroke, with very few adverse events reported. However, caution is advised for those with cardiometabolic diseases, and supervision is recommended to ensure safety. ^{6 7 8 9 10}

How does the High-Intensity + Home Exercise treatment for cognitive impairment differ from other treatments?

This treatment is unique because it combines high-intensity gym exercises with home-based exercise coaching through text messages, which is not commonly used in other treatments for cognitive impairment. It focuses on both high-intensity interval training (HIIT) and continuous moderate exercise (CME), aiming to improve cognitive function through a structured exercise regimen. ^{11 12 13 14 15}

What is the purpose of this trial?

People aging with HIV are at higher risk for Alzheimer's disease and related dementias, and although physical activity is a promising target to mitigate such risk, this population engages in low levels of physical activity. Few studies have tested cognitive effects of exercise interventions or examined mechanisms of adherence to long-term exercise among diverse samples of midlife and older people with HIV. The current study will leverage an existing R01 to address these gaps and provide implications for development of personalized approaches for the treatment and prevention of cognitive impairment and dementia in older people with HIV.

Eligibility Criteria

This trial is for older individuals living with HIV who have low viral loads, are on stable antiretroviral therapy, experience fatigue, and lead a sedentary lifestyle. They must be willing to exercise regularly and able to receive text messages. Exclusions include severe health conditions like heart failure, uncontrolled hypertension or diabetes, recent major surgery or injury, and certain medication uses.

Inclusion Criteria

You do not engage in physical activity that makes you sweat at least 3 days a week, and you haven't done regular strength training in the past 3 months.

Willing to engage in a supervised exercise program 3 times/week for 4 months

Weight <450 lbs

Exclusion Criteria

Active substance abuse or other factors that could prevent compliance or safety with study visits, at the discretion of the site investigator

I have been on stable doses of sex hormone therapy for more than 3 months.

I have been on a stable dose of hormone replacement for more than 3 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo 4 months of supervised high-intensity interval training (HIIT) or continuous moderate exercise (CME)

16 weeks

Regular in-person exercise sessions

Text-messaging intervention

Participants receive a 3-month text-messaging intervention to improve physical activity adherence

12 weeks

Follow-up

Participants are monitored for cognitive functioning and psychological mechanisms of adherence

12 months

12 month follow-up visit

Treatment Details

Interventions

• Phase 1 Gym Exercise CME
• Phase 1 Gym Exercise HIIT
• Phase 2 Home Exercise Coaching Text Messages
• Phase 2 Home Exercise Control Text Messages

Trial Overview The study tests the effects of high-intensity gym exercises followed by home exercise coaching via text messages on cognitive function in older people with HIV. It aims to see if these interventions can improve brain health and establish long-term exercise habits.

Participant Groups

Group I: High-Intensity Interval Training (HIIT) Active Control 3 Interventions

Following a 5-minute warm-up at 50% VO2peak, high and moderate-intensity exercise bouts alternate, progressing to five bouts of 4-minute high-intensity exercise (90% VO2peak), alternating with four 3-minute bouts of moderate-intensity exercise (50% VO2peak) by week 8, followed by a 5 minute cool-down. The total exercise time is 42 minutes.

Group II: Continuous Moderate Exercise (CME) Active Control 3 Interventions

Following a 4 minute warm-up at 50% VO2peak, the participant walks for up to 42 continuous minutes at 60% VO2peak172, followed by a 4 minute cool-down. The total exercise time is 50 minutes.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

University of Colorado, Denver

Collaborator

Trials

1,842

Recruited

3,028,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

University of Washington

Collaborator

Trials

1,858

Recruited

2,023,000+

Findings from Research

The study demonstrated that using voice-controlled intelligent personal assistants (VIPAs) to deliver a home-based exercise program to 15 older adults was safe and feasible, with a 100% retention rate over 12 weeks.

Participants showed excellent adherence to the exercise regimen, completing 115% of the prescribed exercises without any reported adverse events, indicating that VIPAs can effectively support independent exercise in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delivery of Home-Based Exercise Interventions in Older Adults Facilitated by Amazon Alexa: A 12-week Feasibility Trial. Jansons, P., Dalla Via, J., Daly, RM., et al.[2022]

A smartphone-enabled, home-based cardiac rehabilitation program was found to be feasible for veterans with coronary heart disease, with 13 out of 18 participants completing the full 12-week intervention.

Participants showed significant improvements in functional capacity and systolic blood pressure, indicating that this approach can effectively enhance health outcomes while maintaining high levels of patient satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a Smartphone-enabled Cardiac Rehabilitation Program in Male Veterans With Previous Clinical Evidence of Coronary Heart Disease. Harzand, A., Witbrodt, B., Davis-Watts, ML., et al.[2023]

A mobile video-guided home exercise program significantly improved exercise adherence (75.6% vs. 55.2%) and self-efficacy for exercise compared to a standard paper-based program in stroke recovery patients over three months.

Participants using the video-guided program also showed greater improvements in mobility levels (MFAC gain of 1.7 vs. 1.0) but did not demonstrate significant differences in basic activities of daily living (ADL) compared to the control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot study on comparisons between the effectiveness of mobile video-guided and paper-based home exercise programs on improving exercise adherence, self-efficacy for exercise and functional outcomes of patients with stroke with 3-month follow-up: A single-blind randomized controlled trial. Chung, BPH., Chiang, WKH., Lau, H., et al.[2022]

Phase II cardiac exercise therapy (CET) significantly improved exercise capacity in patients with acute myocardial infarction (AMI), as evidenced by increased maximal metabolic equivalents (METs) after 8 weeks of training.

The therapy also led to an increase in high-density lipoprotein cholesterol (HDL-C) levels, which is beneficial for heart health, indicating that CET not only enhances physical recovery but also positively impacts coronary risk factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supervised Phase II Cardiac Exercise Therapy Shortens the Recovery of Exercise Capacity in Patients with Acute Myocardial Infarction. Lee, CW., Wang, JH., Hsieh, JC., et al.[2021]

A study involving 90 coronary artery disease patients found that a short home-based exercise program with telemonitoring was as effective as a prolonged center-based program in maintaining exercise capacity one year after cardiac rehabilitation.

All groups, including a control group, showed stable exercise capacity and physical activity levels, with 85% of patients meeting international physical activity guidelines, indicating that home-based interventions can support ongoing physical activity post-rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-based exercise with telemonitoring guidance in patients with coronary artery disease: Does it improve long-term physical fitness? Avila, A., Claes, J., Buys, R., et al.[2021]

Functional training (FT) can lead to significant energy expenditure (EE) and higher intensity workouts compared to moderate continuous walking (WLK), making it effective for improving cardiorespiratory fitness.

In a study of 25 healthy individuals, FT sessions resulted in higher relative intensity and perceived exertion, suggesting that FT is a beneficial option for health-oriented exercise programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Energy Expenditure, Intensity, and Perceived Effort in Recreational Functional Training. Mangona, L., Brasil, IA., Prista, A., et al.[2023]

Circuit class therapy can provide sufficient exercise dosage to induce a cardiorespiratory fitness effect in 62% of adults with severe traumatic brain injury, based on caloric expenditure criteria.

Providing feedback from heart rate monitors did not significantly influence exercise intensity or the time spent in the target heart rate zone during the therapy sessions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Circuit class therapy can provide a fitness training stimulus for adults with severe traumatic brain injury: a randomised trial within an observational study. Hassett, LM., Moseley, AM., Whiteside, B., et al.[2012]

High-intensity interval training (HIIT) was found to be safe and feasible for patients with lacunar stroke, with no adverse events reported during the home-based intervention involving 71 participants.

While HIIT did not significantly improve cardiorespiratory fitness compared to usual care, it did increase the time spent on vigorous-intensity activity, suggesting potential benefits in physical activity levels for stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Home-Based High-Intensity Interval Training in Patients With Lacunar Stroke: A Randomized Controlled Trial. Steen Krawcyk, R., Vinther, A., Petersen, NC., et al.[2023]

High-intensity interval training (HIIT) is as effective, if not more so, than traditional moderate-intensity continuous training (MICT) for patients with cardiovascular disease, based on a systematic review of 23 studies involving 1117 participants.

The safety profile of HIIT in cardiac rehabilitation is promising, with only one major cardiovascular adverse event reported per 17,083 training sessions, indicating that HIIT can be safely implemented in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-Intensity Interval Training for Patients With Cardiovascular Disease-Is It Safe? A Systematic Review. Wewege, MA., Ahn, D., Yu, J., et al.[2021]

A systematic review of 11 studies involving 156 clinically stable patients with cardiometabolic diseases found that high-intensity interval exercise (HIIE) can lead to adverse responses in about 8% of individuals, indicating a higher risk compared to moderate-intensity exercise.

It is recommended that patients with cardiometabolic diseases who wish to engage in HIIE should be clinically stable, have prior experience with moderate-intensity exercise, and exercise under supervision to ensure safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What Doesn't Kill You Makes You Fitter: A Systematic Review of High-Intensity Interval Exercise for Patients with Cardiovascular and Metabolic Diseases. Levinger, I., Shaw, CS., Stepto, NK., et al.[2022]

This study aims to determine the most effective type of exercise for improving cognitive function in individuals with mild cognitive impairment (MCI) or dementia through a systematic review and network meta-analysis of various exercise types.

The findings will help guide clinical practices in nursing by identifying which specific domains of cognitive function respond best to different exercise interventions, ultimately optimizing therapy for patients with MCI or dementia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The relative effectiveness of different types of exercise for people with Mild Cognitive Impairment or dementia: Systematic review protocol. Zhao, X., Huang, X., Li, B., et al.[2021]

A systematic review of 29 randomized controlled trials involving 2458 patients with cognitive impairment found that multicomponent exercise is the most effective type of exercise for improving global cognition, with a significant effect size (SMD = 0.84).

Short-duration (≤45 min), vigorous intensity, and high-frequency (5-7 times/week) exercises also showed strong efficacy in enhancing cognitive function, indicating that these specific exercise characteristics are beneficial for older adults with cognitive impairment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Which Specific Exercise Models Are Most Effective on Global Cognition in Patients with Cognitive Impairment? A Network Meta-Analysis. Yang, J., Dong, Y., Yan, S., et al.[2023]

Multicomponent exercise programs, which include aerobic, endurance, balance, and flexibility exercises, significantly improve cognitive function and physical abilities in individuals with dementia, showing a notable effect on global cognition and executive function based on a review of 21 studies.

The exercise interventions also enhance activities of daily living and muscle strength, indicating that multicomponent exercise is a promising management strategy for both dementia and mild cognitive impairment (MCI).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Multicomponent Exercise on Cognition, Physical Function and Activities of Daily Life in Older Adults With Dementia or Mild Cognitive Impairment: A Systematic Review and Meta-analysis. Yan, J., Li, X., Guo, X., et al.[2023]

A systematic review of 16 studies involving 1180 participants with Alzheimer's disease or Mild Cognitive Impairment found that separate exercise combined cognitive training (ECT) was the most effective for improving overall cognitive function, with a high probability of being the best approach.

For enhancing memory function specifically, interactive ECT showed the greatest effectiveness, while the best method for improving executive function remains unclear, as both dual-task and separate modalities had similar effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The relative effectiveness of different combination modes for exercise and cognitive training on cognitive function in people with mild cognitive impairment or Alzheimer's disease: a network meta-analysis. Zhao, X., Huang, X., Cai, Y., et al.[2023]

A systematic review of 7 randomized controlled trials found that High-Intensity Functional Training (HIFT) may improve general cognition in older adults with cognitive impairment, with two studies showing positive effects using progressive HIFT protocols.

However, the overall results were mixed, as four studies reported no significant cognitive changes, indicating that the effectiveness of HIFT may vary based on intervention protocols and measurement methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of High-Intensity Functional Training on Cognition in Older Adults with Cognitive Impairment: A Systematic Review. Rivas-Campo, Y., García-Garro, PA., Aibar-Almazán, A., et al.[2023]

References

1. France pubmed.ncbi.nlm.nih.gov

Delivery of Home-Based Exercise Interventions in Older Adults Facilitated by Amazon Alexa: A 12-week Feasibility Trial. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Feasibility of a Smartphone-enabled Cardiac Rehabilitation Program in Male Veterans With Previous Clinical Evidence of Coronary Heart Disease. [2023]

3. Singapore pubmed.ncbi.nlm.nih.gov

Pilot study on comparisons between the effectiveness of mobile video-guided and paper-based home exercise programs on improving exercise adherence, self-efficacy for exercise and functional outcomes of patients with stroke with 3-month follow-up: A single-blind randomized controlled trial. [2022]

4. Japan pubmed.ncbi.nlm.nih.gov

Supervised Phase II Cardiac Exercise Therapy Shortens the Recovery of Exercise Capacity in Patients with Acute Myocardial Infarction. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Home-based exercise with telemonitoring guidance in patients with coronary artery disease: Does it improve long-term physical fitness? [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Energy Expenditure, Intensity, and Perceived Effort in Recreational Functional Training. [2023]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Circuit class therapy can provide a fitness training stimulus for adults with severe traumatic brain injury: a randomised trial within an observational study. [2012]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Effect of Home-Based High-Intensity Interval Training in Patients With Lacunar Stroke: A Randomized Controlled Trial. [2023]

9. England pubmed.ncbi.nlm.nih.gov

High-Intensity Interval Training for Patients With Cardiovascular Disease-Is It Safe? A Systematic Review. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

What Doesn't Kill You Makes You Fitter: A Systematic Review of High-Intensity Interval Exercise for Patients with Cardiovascular and Metabolic Diseases. [2022]

11. England pubmed.ncbi.nlm.nih.gov

The relative effectiveness of different types of exercise for people with Mild Cognitive Impairment or dementia: Systematic review protocol. [2021]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Which Specific Exercise Models Are Most Effective on Global Cognition in Patients with Cognitive Impairment? A Network Meta-Analysis. [2023]

13. United States pubmed.ncbi.nlm.nih.gov

Effect of Multicomponent Exercise on Cognition, Physical Function and Activities of Daily Life in Older Adults With Dementia or Mild Cognitive Impairment: A Systematic Review and Meta-analysis. [2023]

14. England pubmed.ncbi.nlm.nih.gov

The relative effectiveness of different combination modes for exercise and cognitive training on cognitive function in people with mild cognitive impairment or Alzheimer's disease: a network meta-analysis. [2023]

15. Switzerland pubmed.ncbi.nlm.nih.gov

The Effects of High-Intensity Functional Training on Cognition in Older Adults with Cognitive Impairment: A Systematic Review. [2023]