Dose-response relationship of cardiorespiratory fitness adaptation to controlled endurance training in sedentary older adults.
Guoyuan Huang, Ru Wang, Peijie Chen...
https://pubmed.ncbi.nlm.nih.gov/25901000/Actively Recruiting
Led by Arizona State University · Updated on 2026-05-05
216
Participants Needed
1
Research Sites
65 weeks
Total Duration
Researchers are evaluating the effects of six months of aerobic exercise on older adults aged 65 years or older who have mild cognitive impairment MCI or probablepossible mild Alzheimers disease AD. This Phase II mechanistic Sequential, Multiple Assignment, Randomized Trial SMART aims to assess how aerobic exercise influences aerobic fitness, brain white matter changes, and patient-centered outcomes. The study also seeks to identify the best exercise approaches to improve aerobic fitness and understand how exercise impacts memory mechanisms in early AD. Participants are assigned to one of several exercise programs moderate intensity continuous training MICT cycling for 30-50 minutes three times a week, chair-based stretching for 30-50 minutes three times a week, a combination of MICT followed by high-intensity interval training HIIT cycling for 40 minutes three times a week, or MICT followed by strength-building exercises three times a week for three months. The study includes an initial 3-month exercise phase with possible adaptation based on fitness response, lasting up to six months. During the study, participants will undergo cognitive testing and exercise assessments five times over one year, brain MRI scans three times in the same period, and monthly follow-ups discussing health and wellness. Researchers will measure peak oxygen consumption and white matter hyperintensity volume at baseline and six months, along with memory, physical function, behavioral symptoms, caregiver burden, quality of life, and blood biomarkers over one year. The trial includes safety monitoring and aims to improve understanding of exercise effects on early Alzheimers disease.
CONDITIONS
A SMART Trial of Adaptive Exercises to Optimize Aerobic-Fitness Responses
K
Kristi Spieleder, MS
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Arizona State University
Lead Sponsor
Banner Alzheimer's Institute
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Moderate Intensity Continuous Training (MICT) | Chair-based Stretch | High-Intensity Interval Training (HIIT) | Combined Aerobic Resistance Exercise (CARE) |
|---|---|---|---|---|
| What is it? | This is a moderate-intensity cycling program aiming for sustained exercise at 50-75% of heart rate reserve, conducted three times a week. | A gentle stretching routine performed in a seated position, lasting 30-50 minutes per session, three times weekly. | A high-intensity cycling regimen with repeated vigorous bouts at 80-90% of heart rate reserve, alternating with recovery periods. | A combined training program involving full-body strength-building exercises followed by moderate-intensity cycling. |
| Role in the trial | Tested as an active aerobic intervention to assess fitness and cognitive outcomes. | Acts as a low-activity control for comparison to aerobic and combined training. | Serves as a high-intensity exercise intervention for within-participant analysis. | Provides a mixed-modality comparison, assessing added value of resistance to aerobic training. |
| Primary use or intent | To potentially improve cardiorespiratory fitness and cognitive function in older adults. | Acts as an attention-matched control, not expected to substantially affect aerobic capacity or cognition. | To evaluate if higher-intensity aerobic intervals provide greater gains in fitness and cognition. | To test whether combining resistance and aerobic training adds benefits for fitness and cognitive outcomes. |
| How it is given or performed | Participants cycle steadily at a set moderate pace for 30-50 minutes, three times per week, as guided by heart rate. | Stretching exercises are led in a chair for 30-50 minutes per session, three times weekly. | Participants complete intervals of vigorous cycling (80-90% heart rate reserve) with periods of active recovery, for 40 minutes, three days weekly. | A session starts with strength exercises then proceeds to 30 minutes of moderate cycling, done three times weekly. |
| Evidence status | Ongoing clinical assessment in the SMART trial aims to determine fitness and cognitive benefits in the target population. Previous studies have shown moderate-intensity aerobic exercise can enhance physical and cognitive function in older adults with cognitive impairment. | Serves primarily as a control; it is not expected to produce major changes in cardiorespiratory fitness or cognitive performance in this population, and published literature supports minimal effect of low-intensity, non-aerobic interventions. | The trial tests HIIT for impact on aerobic fitness and cognition. Broader literature in older adults suggests high-intensity interval training may offer similar or additional benefits compared to moderate-intensity approaches, but less is established in cognitive impairment. | Assessed in the SMART trial for potential additive or synergistic effects. Broader evidence indicates multi-modal programs with both resistance and aerobic components may benefit functional ability and cognition in older adults with cognitive impairment. |
| Important limitations | Not all participants may respond equally to moderate-intensity aerobic activity, and access to exercise resources or supervision can be limiting factors outside of research settings. | This low-activity control is designed not to improve fitness or cognition and may not represent typical standard care or activity levels in the community. | High-intensity intervals are not suitable for everyone due to fitness and medical concerns, and evidence for benefits in cognitively impaired elders is still emerging. | May require specialized instruction and equipment, and the combination of strength and aerobic components can be challenging for some older adults to follow consistently. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants engage in aerobic exercise interventions including moderate intensity continuous training (MICT), chair-based stretch, high-intensity interval training (HIIT), or combined aerobic resistance exercise (CARE) to improve aerobic fitness and examine effects on biomarkers related to Alzheimer's disease.
3 weekly exercise sessions for up to 6 months with assessments at baseline, 3 months, and 6 months
Duration - 6 months after treatment ends
Participants are monitored for memory, physical function, behavioral symptoms, caregiver burden, quality of life, and blood biomarkers up to 12 months from baseline to assess longer-term effects of the interventions.
Visits at 9 and 12 months post-baseline
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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https://pubmed.ncbi.nlm.nih.gov/25884637/Arizona State University
Lead Sponsor
Banner Alzheimer's Institute
Collaborating Sponsor