Effects of Resisted Versus Balance Exercises on Cognitive And Motor Function In Patients With Mild Cognitive Impairment

October 10, 2024 updated by: Riphah International University
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.

Study Overview

Status

Completed

Detailed Description

This randomized clinical trial will be conducted at Aziz Bhatti Shaheed Teaching Hospital Gujrat in seven months after approval of synopsis. The sample size for this trial is 78 patients with MCI. The participants will be randomly allocated into two groups using Online Randomization tool. Group A will receive resisted exercises for 30 minutes and Group B will receive balance exercises for 30 minutes. Participants will receive 3 sessions on alternate days per week for 12 weeks.Montreal Cognitive Assessment (MoCA) and Computerized battery test will be used to assess cognitive impairment, Mini-besTest and Time Up and Go Test (TUG) for balance and motor function.Data will be entered and analysed by using SPSS 26 software.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Punjab
      • Lahore, Punjab, Pakistan, 54660
        • Riphah International University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GROUP A (RESISTED EXERCISES)
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).

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.

Experimental: GROUP B (BALANCE EXERCISES)
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).

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MoCA (Montreal Cognitive Assessment )
Time Frame: 14th week
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).
Time Frame: 16th week
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) :
Time Frame: 16th week
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Muhammad Kashif, PhD-PT, Riphah International University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 25, 2024

Primary Completion (Actual)

July 10, 2024

Study Completion (Actual)

July 10, 2024

Study Registration Dates

First Submitted

March 4, 2024

First Submitted That Met QC Criteria

March 12, 2024

First Posted (Actual)

March 13, 2024

Study Record Updates

Last Update Posted (Actual)

October 15, 2024

Last Update Submitted That Met QC Criteria

October 10, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • REC/RCR&AHS/23/0293

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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