NCT06867016

Brief Summary

The study aims to assess the effects of Bidomain cognitive and aerobic training on both cognitive functioning and quality of life in individuals with mild cognitive impairment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 28, 2025

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

March 4, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 10, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 28, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 2025

Completed
Last Updated

April 8, 2026

Status Verified

April 1, 2026

Enrollment Period

6 months

First QC Date

March 4, 2025

Last Update Submit

April 2, 2026

Conditions

Keywords

CognitionOld agemild cognitive impairmentaerobiccognitive training

Outcome Measures

Primary Outcomes (2)

  • Mini-mental state examination (MMSE)

    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)

    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 Outcomes (1)

  • World health observational quality of life-BREF-100

    8 weeks

Study Arms (2)

Combined Cognitive & Aerobic Training Group

EXPERIMENTAL

The ACT combined training will consist of simultaneous aerobic exercise and cognitive training in a dual-task format.

Other: Combined Cognitive & Aerobics Training

Cognitive Training Group

ACTIVE COMPARATOR

Cognitive training group include cognitive training involving speed processing, memory recall, problem-solving, and visual attention exercises.

Other: Cognitive Training

Interventions

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.

Combined Cognitive & Aerobic Training Group

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.

Cognitive Training Group

Eligibility Criteria

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

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

DHQ Chakwal

Chakwal, Punjab Province, 48800, Pakistan

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Neurological RehabilitationRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Saliha Ashfaq, MS-NMPT*

    Riphah International University

    PRINCIPAL INVESTIGATOR

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

March 4, 2025

First Posted

March 10, 2025

Study Start

February 28, 2025

Primary Completion

August 28, 2025

Study Completion

August 28, 2025

Last Updated

April 8, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations