- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07248709
Comparison of High-Intensity Interval Training and Moderate-Intensity Continuous Training in Mild Cognitive Impairment
Comparison of High-Intensity Interval Training and Moderate-Intensity Continuous Training on Executive Functions, Cardiorespiratory and Physical Fitness in Older Adults With Mild Cognitive Impairment
This study aims to determine the effects of High-Intensity Interval Training (HIIT) and Moderate-Intensity Continuous Training (MICT) on cognitive and physical fitness in community-dwelling adults diagnosed with Mild Cognitive Impairment (MCI).
A double-blinded randomized clinical trial will be conducted for ten months at Ruhama Welfare Foundation Society Lahore and Kainat Patient Care and Old Age Home, Lahore. The sample size is calculated through G-power and 68 participants will be recruited through the non-probability convenience sampling technique. Those who meet the inclusion criteria will be randomized into two groups through the online randomizer tool. Both experimental groups will undergo an 8-week intervention, consisting of three sessions per week with alternate-day training of 38 minutes. The HIIT group will perform exercise with each session consisting of four 4-minute intervals at 85-95% of their maximum heart rate, with 3-minute active recovery periods, while the MICT group will engage in continuous exercise for 28 minutes at 70-75% of their maximum heart rate. Assessment will be done at baseline, after the 4th week, 8th week, and follow-up at 12th week.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Mild cognitive impairment is a syndrome defined as cognitive decline greater than expected for an individual's age and education level but that does not interfere notably with activities of daily life. Prevalence in population-based epidemiological studies ranges from 3% to 19% in adults older than 65 years. Some people with mild cognitive impairment seem to remain stable or return to normal over time, but more than half progress to dementia within 5 years. Mild cognitive impairment can thus be regarded as a risk state for dementia. The amnestic subtype of mild cognitive impairment has a high risk of progression to Alzheimer's disease, and it could constitute a prodromal stage of this disorder. One of the main causes of disability and dependency in older adults globally, dementia ranks as the seventh most common cause of all disorders. Globally, there were 55 million dementia sufferers in 2021; by 2030, that figure is expected to rise to 78 million, and by 2050, it will reach 139 million. Thankfully, there is a chance that postponing dementia onset by five years could cut its prevalence in half globally. Compared to just 3% of the age-matched group, 46% of people with mild cognitive impairment (MCI), an intermediate stage between normal cognition and dementia, will develop dementia within three years. As a result, MCI is a crucial phase in stopping dementia from getting worse. The multi-cognitive function of subjects with MCI declines.
HIIT can enhance cognitive performance through increased blood flow to the brain, promoting neurogenesis and synaptic plasticity, which are crucial for cognitive tasks. MICT also supports cognitive function. HIIT often produces superior results in a shorter time frame. HIIT involves short bursts of high-intensity exercise followed by rest or low-intensity periods, leading to significant cardiovascular adaptations such as increased VO2 max and improved heart efficiency. MICT, while beneficial, requires longer durations to achieve comparable gains in cardiorespiratory fitness (CRF). Engaging in regular physical exercise has been shown to delay age-related physiological and cognitive decline, reduce the risk of common diseases, and improve the subjective quality of life. Meanwhile, a large proportion of older adults are insufficiently physically active, potentially increasing societal health-related challenges connected to a growing older population. It is, therefore, important to provide both effective and attractive exercise methods adapted for this group. One of the proposed key factors in maximizing exercise effects is to exercise beyond moderate intensities, as in high-intensity interval training (HIIT). Although aerobic moderate-intensity continuous training (MICT) is performed at intensities below the anaerobic threshold, HIIT is broadly defined as short, repeated work intervals at an external intensity close to (80%-100%), or above (>100%) the intensity that elicits maximum oxygen uptake (Vo2 max), with passive or low intensity recovery between intervals.
While exercise is a promising intervention for cognitive health, the comparative efficacy of High-Intensity Interval Training (HIIT) and Moderate-Intensity Continuous Training (MICT) in older adults with MCI remains underexplored. This research seeks to provide useful insights examining the effects of HIIT and MICT on executive functions, cardiorespiratory fitness, and overall physical fitness. HIIT's potential time efficiency and physiological benefits may offer significant advantages over traditional exercise methods. The findings could inform clinical practice, shape public health guidelines, and lead to more effective exercise interventions, ultimately enhancing the quality of life for older adults at risk of cognitive decline.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Punjab Province
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Lahore, Punjab Province, Pakistan, 64350
- Khursheed Oldage Home and Nursing Care
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Lahore, Punjab Province, Pakistan
- Alara Healthcare Clinic
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- older adults who had been diagnosed with MCI according to Peterson's criteria [Montreal Cognitive Assessment (MoCA) score <26 for those with 12 years or more of education and <25 for those with less than 12 years of education; activity of daily living scale ≤23; no clinical diagnosis of dementia]
- older adults who are physically normal (the six-item Katz Activities of Daily Living Scale should all be evaluated as "independent")
Exclusion Criteria:
- Participants who have medical problems or co-morbidities that interdict their participation in the study.
- Unable to walk without an assistive device
- Diagnosed with neurodegenerative diseases such as Alzheimer's disease
- Having regular exercise habits (defined as exercise for ≥150 min per week).
- Participating in other ongoing intervention study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Group A
The High-Intensity Interval Training Group (HIIT)
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The HIIT group will engage in 28 min of alternating high-intensity and low-intensity exercise, where the high-intensity phase will be at 85-90% of maximum heart rate for 4 min, followed by a 3-min recovery period at 50-60% of maximum heart rate, repeated four times on a treadmill or stationary bicycle.
(RPE ~16 on Borg scale) Total duration will be 38 minutes including warm up and cool down period.
|
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Experimental: Group B
Moderate-Intensity Continuous Training (MICT)
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The MICT group's training will consist of continuous aerobic exercise for 28 min at 60-70% of maximum heart rate on a treadmill or stationary bicycle.
(RPE ~13 on Borg scale) Total duration will be 38 minutes including warm up and cool down period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Montreal Cognitive Assessment (MoCA)
Time Frame: Assessment at baseline, after the 4th week, 8th week, and follow-up at 12th week.
|
The Montreal Cognitive Assessment (MoCA) is a one-page, 30-point cognitive screening measurement scale that takes about 10 minutes to administer.
There are 12 subtasks in the MoCA test that include memory, visuospatial orientation, executive functioning, phonemic fluency, and two-item abstract thinking task, attention, concentration, and working memory, language, orientation to time and place.
A score of 26 is a cutoff score to differentiate between normal and abnormal.
It has been extensively validated for its reliability and effectiveness in detecting cognitive deficits.
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Assessment at baseline, after the 4th week, 8th week, and follow-up at 12th week.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Trail Making Test
Time Frame: Assessment at baseline, after the 4th week, 8th week, and follow-up at 12th week.
|
The Trail Making Test (TMT) is a widely used neuropsychological assessment tool that evaluates cognitive flexibility, executive function, and processing speed.
It consists of two parts: TMT-A and TMT-B, each designed to measure different cognitive abilities.
TMT-A: This part requires the participant to connect a series of numbered circles in ascending order (1-2-3-4...).
It primarily assesses visuoperceptual abilities, such as visual scanning and motor speed.
TMT-B: In this part, participants alternate between numbers and letters (1-A-2-B-3-C...), which adds complexity by requiring task-switching and working memory.
This portion reflects higher-order executive functions, including cognitive flexibility and the ability to shift attention between tasks.
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Assessment at baseline, after the 4th week, 8th week, and follow-up at 12th week.
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The Short Physical Performance Battery (SPPB)
Time Frame: Assessment at baseline, after the 4th week, 8th week, and follow-up at 12th week.
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The Short Physical Performance Battery (SPPB) is an objective assessment tool used to evaluate lower extremity functioning and physical performance in older adults including those with mild cognitive impairment (MCI).
It consists of three tests: Balance test, Gait speed test and Chair stand test.
Each test is scored from 0-4 points.
Total SPPB score ranges from 0 (worst performance) to 12 (best performance).
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Assessment at baseline, after the 4th week, 8th week, and follow-up at 12th week.
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6-Minute Walk Test (6MWT)
Time Frame: Assessment at baseline, after the 4th week, 8th week, and follow-up at 12th week.
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The 6-Minute Walk Test (6MWT) aims to determine how far a person can walk in 6 minutes on a flat, hard surface.
The test evaluates the integrated response of multiple bodily systems during exercise, including the respiratory, cardiovascular, and musculoskeletal systems.
The person walks back and forth along a measured course, typically 30 meters long.
They are instructed to cover as much distance as possible in 6 minutes.
Participants can slow down or rest if needed but should resume walking when able.
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Assessment at baseline, after the 4th week, 8th week, and follow-up at 12th week.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Aruba Saeed, PhD, Riphah International University
Publications and helpful links
General Publications
- Shao Z, Huang J, Feng H, Hu M. Optimizing the physical activity intervention for older adults with mild cognitive impairment: a factorial randomized trial. Front Sports Act Living. 2024 May 7;6:1383325. doi: 10.3389/fspor.2024.1383325. eCollection 2024.
- de Lima NS, De Sousa RAL, Amorim FT, Gripp F, Diniz E Magalhaes CO, Henrique Pinto S, Peixoto MFD, Monteiro-Junior RS, Bourbeau K, Cassilhas RC. Moderate-intensity continuous training and high-intensity interval training improve cognition, and BDNF levels of middle-aged overweight men. Metab Brain Dis. 2022 Feb;37(2):463-471. doi: 10.1007/s11011-021-00859-5. Epub 2021 Nov 11.
- Tsai CL, Pai MC, Ukropec J, Ukropcova B. The Role of Physical Fitness in the Neurocognitive Performance of Task Switching in Older Persons with Mild Cognitive Impairment. J Alzheimers Dis. 2016 Apr 23;53(1):143-59. doi: 10.3233/JAD-151093.
- Martin-Smith R, Cox A, Buchan DS, Baker JS, Grace F, Sculthorpe N. High Intensity Interval Training (HIIT) Improves Cardiorespiratory Fitness (CRF) in Healthy, Overweight and Obese Adolescents: A Systematic Review and Meta-Analysis of Controlled Studies. Int J Environ Res Public Health. 2020 Apr 24;17(8):2955. doi: 10.3390/ijerph17082955.
- Wu Q, Niu X, Zhang Y, Song J, Chi A. A Comparative Study of Inhibition Function between High-Intensity Interval Training and Moderate-Intensity Continuous Training in Healthy People: A Systematic Review with Meta-Analysis. Int J Environ Res Public Health. 2023 Feb 6;20(4):2859. doi: 10.3390/ijerph20042859.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/0268 Sadia Khalid
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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