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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Pakistan
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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).
Other: RESISTED EXERCISES

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).
Other: BALANCE 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Riphah International University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 25, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 10, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 10, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 4, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 13, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 15, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 10, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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