- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06867016
Effects of Bidomain Cognitive and Aerobic Training on Cognitive Functioning in Mild Cognitive Impairment.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab Province
-
Chakwal, Punjab Province, Pakistan, 48800
- DHQ Chakwal
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Older adults 60 years & above
- With normal vision and color perception
- Independent Individual capable of carrying out daily tasks
- Individuals scoring 21-25 on the Mini-Mental State Examination (MMSE)
Exclusion Criteria:
- Medication affecting the exercise capacity of individual
- Regular participation in aerobic training for the last six months
- Cardiovascular or other diseases that do not allow physical activity
- A diagnosed severe psychiatric disease (e.g., depression)
- Patients with cognitive impairment or other neurological impairments due to AD or dementia.
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 |
|---|---|
|
Experimental: Combined Cognitive & Aerobic Training Group
The ACT combined training will consist of simultaneous aerobic exercise and cognitive training in a dual-task format.
|
The ACT combined training will consist of simultaneous aerobic exercise and cognitive training in a dual-task format, conducted twice a week for 8 weeks.
The aerobic training (AT) will consist of twice-weekly sessions that include yoga, brisk walking, pedaling exercises, and step aerobics, alongside cognitive training involving speed processing, memory recall, problem-solving, and visual attention exercises.
Each session will last approximately 20 minutes, and assessments will be performed at baseline, 4th week, and 8th week.
|
|
Active Comparator: Cognitive Training Group
Cognitive training group include cognitive training involving speed processing, memory recall, problem-solving, and visual attention exercises.
|
Cognitive training involving speed processing, memory recall, problem-solving, and visual attention exercises.
Each session will last approximately 20 minutes, and assessments will be performed at baseline, the 4th week, and the 8th week.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mini-mental state examination (MMSE)
Time Frame: 8 weeks
|
The Mini-Mental State Examination (MMSE) is a widely used screening test for cognitive deficits, with scores ranging from 0 to 30.
A score of 24 or below indicates potential cognitive impairment, particularly for patients aged 65 and older.
The MMSE evaluates verbal abilities, where scores of 30-27 are considered normal, while lower scores indicate mild (26-21 points), moderate (20-10 points), or severe (9-0 points) dementia.
|
8 weeks
|
|
Short Cognitive Test (SKT)
Time Frame: 8 weeks
|
The SKT (Syndrom-Kurz-Test) is a recognized short cognitive performance test used to detect attention and memory deficits. It features subtest norm values ranging from 0 to 3, with a total score ranging from 0 to 27, where higher scores indicate more severe cognitive impairment. The SKT assesses memory performance and attention based on processing speed. The SKT (Syndrom-Kurz-Test) is a recognized short cognitive performance test used to detect attention and memory deficits. It features subtest norm values ranging from 0 to 3, with a total score ranging from 0 to 27, where higher scores indicate more severe cognitive impairment. The SKT assesses memory performance and attention based on processing speed. |
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
World health observational quality of life-BREF-100
Time Frame: 8 weeks
|
Quality of life (QOL) is essential for understanding the subjective experience of mild cognitive impairment (MCI) and its impact on individuals.
In the WHOQOL-BREF questionnaire, scores range from 0 (worst possible health) to 100 (best possible health), with higher scores indicating better QOL.
Each domain score is calculated by taking the mean of items within that domain and then transformed linearly to a 0-100 scale
|
8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Saliha Ashfaq, MS-NMPT*, Riphah International University
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/MS-PT/O2029 Saliha Ashfaq
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.
Clinical Trials on Mild Cognitive Impairment
-
Saglik Bilimleri UniversitesiAnkara UniversityRecruitingAmnestic Mild Cognitive Impairment | Amnestic Mild Cognitive DisorderTurkey
-
Masaryk UniversityRecruitingMild Cognitive Impairment (MCI) Amnestic | Lewy Body Disease With Mild Cognitive Impairment | Parkinson's Disease With Mild Cognitive ImpairmentCzechia
-
BaycrestCentre for Aging and Brain Health InnovationUnknownNeurocognitive Disorders | Cognitive Dysfunction | Mental Disorder | Cognitive Impairment, Mild | Cognitive Disorder | Nonamnestic Mild Cognitive ImpairmentCanada
-
Singapore General HospitalSingapore Health ServicesNot yet recruitingMild Cognitive Impairment (MCI) | Mild Cognitive Impairment
-
Xuanwu Hospital, BeijingNot yet recruitingMild Cognitive Impairment (MCI)China
-
The Hong Kong Polytechnic UniversityJohns Hopkins University; The University of Hong Kong; University of ReadingNot yet recruitingMild Cognitive Impairment (MCI)Hong Kong
-
Universidad Complutense de MadridAB Biotics, SANot yet recruitingMild Cognitive Impairment (MCI)Spain
-
University of SheffieldNot yet recruitingMild Cognitive Impairment (MCI)United Kingdom
-
The Hong Kong Polytechnic UniversityRecruitingMild Cognitive Impairment (MCI)Hong Kong
-
Mackay Memorial HospitalBened Biomedical Co., Ltd.TerminatedMild Cognitive Impairment (MCI)Taiwan
Clinical Trials on Combined Cognitive & Aerobics Training
-
Federal University of São PauloCompleted
-
Fundació Sant Joan de DéuParc Sanitari Sant Joan de Déu; Solidaritat Sant Joan de Déu; FluidraRecruiting
-
Chiang Mai UniversityCompletedMild Cognitive ImpairmentThailand
-
Hospital de Clinicas de Porto AlegreCompleted
-
Biruni UniversityRecruiting
-
Riphah International UniversityCompletedDiabetic Peripheral NeuropathyPakistan
-
University Hospital, Clermont-FerrandUniversity of Clermont Auvergne (UCA) / LAPSCONot yet recruiting
-
University of BarcelonaUniversity of Pittsburgh; Germans Trias i Pujol Hospital; Ministerio de Economía... and other collaboratorsCompletedAging | Cognitive Function 1, SocialSpain
-
Taipei Medical UniversityNot yet recruitingCognitive Impairment | Mild Cognitive Impairment
-
Johns Hopkins UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Terminated