NCT06308237

Brief Summary

Mild cognitive impairment affects older adults and it includes memory and attentions deficits, and problem-solving difficulties in activities of daily living. Resisted exercises is considered a viable strategy to improve balance and motor function in older population. Balance exercises comprises proprioceptive, visual and motor learning to a larger degree and has positive effects on memory and spatial cognition and improves balance and motor function. This study aims to determine the effects of resisted and balance exercises on cognition and motor function in patients with mild cognitive impairment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2024

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 25, 2024

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

March 4, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 13, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2024

Completed
Last Updated

October 15, 2024

Status Verified

October 1, 2024

Enrollment Period

5 months

First QC Date

March 4, 2024

Last Update Submit

October 10, 2024

Conditions

Keywords

CognitionMotor controlRandomized clinical trial

Outcome Measures

Primary Outcomes (3)

  • MoCA (Montreal Cognitive Assessment )

    The Montreal Cognitive Assessment (MoCA) will be used as a screening tool as well as assessment tool for cognition. It is a one-page, 30-point cognitive screening measurement scale that takes about 10 minutes to administer

    14th week

  • Mini-Balance Evaluation Systems Test (BESTest).

    It aims to target and identify 6 different balance control systems so that specific rehabilitation approaches can be designed for different balance deficits.It is a 14-item test scored on a 3-level ordinal scale.

    16th week

  • Timed UP and GO Test (TUG) :

    The Timed Up and Go test (TUG) will be used as a screening as well as assessment scale for balance and motor function. It can measures in seconds the time it takes a subject to rise from a chair, walk a distance of 3 meters, turn, walk back to the chair and sit down.This test has been used extensively in geriatric medicine to examine balance, gait speed, and functional ability that would be required for the performance of basic activities of daily living in older people.

    16th week

Study Arms (2)

GROUP A (RESISTED EXERCISES)

EXPERIMENTAL

Group A will receive a session of resisted exercises for 30 minutes. Treatment session will be given for 3 days per week for 12 weeks. This resisted training exercise program consist of three phases: Warm-up phase (5 minutes, after Warm-Up phase 20 minutes resisted exercise training then cooling phase (5 minutes).

Other: RESISTED EXERCISES

GROUP B (BALANCE EXERCISES)

EXPERIMENTAL

Group B will receive a session of Balance exercises for 30 minutes. Treatment session will be given for 3 days per week for 12 weeks. This balance exercise program consist of three phases:Warm-up phase (5 minutes), after Warm-Up phase, 20 minutes balance exercise training then cooling phase (5 minutes).

Other: BALANCE EXERCISES

Interventions

Patients will perform Chest plank for 30 seconds with 4 repetitions. Then the Participants will perform these exercises for 1 minute each with 4 repetitions: Wide grip lateral pull down , Lying triceps press, Sit up squats, Barbell curl each. And will perform Thigh adduction for1 minute with 2 repititions.

GROUP A (RESISTED EXERCISES)

Static and dynamic balance exercises will include: Patients will perform Arm abduction holding a half-kg dumbbell, Opposite arm and leg in a quadruped position, Walking in a tandem stance(forward and backward), Turning and bending to the sides in a standing position, Pass through obstacles in a spiral, for 2 minutes each. Then they will perform throwing a medicine ball to investigator and back while trying to maintain balance, Tandem stance, Walking backwards, Two-leg bridge as well as single (2 repetitions), Leg bridge (raising the other leg), walking on the heel, performing rhythmic movements while stepping on a circular environment and balance board exercises, for 1 minute each. And will Walk up and down the stairs for 3 minutes.

GROUP B (BALANCE EXERCISES)

Eligibility Criteria

Age60 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with Mild Cognitive Impairment. (Having score between 18 - 24) on MoCA.
  • Participants with Both Genders will be included .
  • The Age limit for the participants will be 60 to 75 years.
  • Patients having Independence of life (ability to walk independently without any walking aid).

You may not qualify if:

  • Previous and current History Cardiovascular, neurological, psychiatric and motor disorders like (fractures, diagnosis of Osteoporosis)
  • Patients taking any medication for mild cognition.
  • Depressive symptoms, acute and chronic conditions that would preclude exercise, regular exercise (\>30 min/day, \>3days/week).
  • Patients having estrogen replacement therapy.
  • Simultaneous participation in other studies.
  • Regular physical activity (once a week during the last 3 months); physio therapeutic treatment in the last 3 months.
  • Diseases that promote incapacity; severe visual deficiency; recurrent vertigo; and uncontrolled systemic arterial hypertension.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University

Lahore, Punjab Province, 54660, Pakistan

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Muhammad Kashif, Phd-PT

    Riphah International University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The study would be single blinded as assessor of the study would be kept blind of the treatment groups to which patient will be allocated.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2024

First Posted

March 13, 2024

Study Start

February 25, 2024

Primary Completion

July 10, 2024

Study Completion

July 10, 2024

Last Updated

October 15, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations