NCT07248709

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 5, 2025

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

November 18, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 25, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 12, 2026

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
Last Updated

December 30, 2025

Status Verified

December 1, 2025

Enrollment Period

5 months

First QC Date

November 18, 2025

Last Update Submit

December 29, 2025

Conditions

Keywords

High-Intensity Interval TrainingModerate-Intensity Continuous TrainingMild Cognitive ImpairmentExecutive FunctionPhysical FitnessCardiorespiratory Fitness

Outcome Measures

Primary Outcomes (1)

  • Montreal Cognitive Assessment (MoCA)

    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.

    Assessment at baseline, after the 4th week, 8th week, and follow-up at 12th week.

Secondary Outcomes (4)

  • Cognitive Assessment Battery (CAB)

    Assessment at baseline, after the 4th week, 8th week, and follow-up at 12th week.

  • Trail Making Test

    Assessment at baseline, after the 4th week, 8th week, and follow-up at 12th week.

  • The Short Physical Performance Battery (SPPB)

    Assessment at baseline, after the 4th week, 8th week, and follow-up at 12th week.

  • 6-Minute Walk Test (6MWT)

    Assessment at baseline, after the 4th week, 8th week, and follow-up at 12th week.

Study Arms (2)

Group A

EXPERIMENTAL

The High-Intensity Interval Training Group (HIIT)

Other: High-Intensity Interval Training (HIIT)

Group B

EXPERIMENTAL

Moderate-Intensity Continuous Training (MICT)

Other: Moderate-Intensity Continuous Training

Interventions

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.

Group A

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.

Group B

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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")

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Khursheed Oldage Home and Nursing Care

Lahore, Punjab Province, 64350, Pakistan

RECRUITING

Ruhama Welfare Foundation Society

Lahore, Punjab Province, Pakistan

RECRUITING

Related Publications (5)

  • 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.

    PMID: 38774280BACKGROUND
  • 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.

    PMID: 34762211BACKGROUND
  • 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.

    PMID: 27128369BACKGROUND
  • 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.

    PMID: 32344773BACKGROUND
  • 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.

    PMID: 36833556BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Aruba Saeed, PhD

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sadia Khalid, MSPT-NM

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2025

First Posted

November 25, 2025

Study Start

November 5, 2025

Primary Completion

April 12, 2026

Study Completion

April 30, 2026

Last Updated

December 30, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations