Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06308237
Other study ID # REC/RCR&AHS/23/0293
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 25, 2024
Est. completion date June 25, 2024

Study information

Verified date March 2024
Source Riphah International University
Contact Muhammad Kashif, PhD-PT
Phone 03333125303
Email kashif.shaffi@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 66
Est. completion date June 25, 2024
Est. primary completion date June 20, 2024
Accepts healthy volunteers No
Gender All
Age group 60 Years to 75 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
Pakistan Riphah International University Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary Computerized battery test (CBT) The battery is designed for preclinical screening of abnormal cognitive decline. It comprises 8 sub tests that assess 4 cognitive domains: attention, executive function, processing speed, and memory (verbal, nonverbal, functional, and incidental). 16th week
See also
  Status Clinical Trial Phase
Completed NCT04513106 - Promoting Advance Care Planning for Persons With Early-stage Dementia in the Community: a Feasibility Trial N/A
Recruiting NCT06011681 - The Rapid Diagnosis of MCI and Depression in Patients Ages 60 and Over
Recruiting NCT04522739 - Spironolactone Safety in African Americans With Mild Cognitive Impairment and Early Alzheimer's Disease Phase 4
Active, not recruiting NCT03167840 - Falls Prevention Through Physical And Cognitive Training in Mild Cognitive Impairment N/A
Active, not recruiting NCT03676881 - Longitudinal Validation of a Computerized Cognitive Battery (Cognigram) in the Diagnosis of Mild Cognitive Impairment and Alzheimer's Disease
Not yet recruiting NCT05041790 - A Clinical Trial to Evaluate the Efficacy and Safety of Choline Alfoscerate Compared to Placebo in Patients With Degenerative Mild Cognitive Impairment Phase 4
Recruiting NCT04121156 - High Definition Transcranial Direct Current Stimulation (HD-tDCS) in Patients With Mild Cognitive Impairment N/A
Recruiting NCT03605381 - MORbidity PRevalence Estimate In StrokE
Completed NCT02774083 - Cognitive Training Using Feuerstein Instrumental Enrichment N/A
Completed NCT01315639 - New Biomarker for Alzheimer's Disease Diagnostic N/A
Enrolling by invitation NCT06023446 - Can (Optical Coherence Tomography) Pictures of the Retina Detect Alzheimer's Disease at Its Earliest Stages?
Completed NCT04567745 - Automated Retinal Image Analysis System (EyeQuant) for Computation of Vascular Biomarkers Phase 1
Recruiting NCT05579236 - Cortical Disarray Measurement in Mild Cognitive Impairment and Alzheimer's Disease
Completed NCT03583879 - Using Gait Robotics to Improve Symptoms of Parkinson's Disease N/A
Terminated NCT02503501 - Intranasal Glulisine in Amnestic Mild Cognitive Impairment and Probable Mild Alzheimer's Disease Phase 2
Not yet recruiting NCT03740178 - Multiple Dose Trial of MK-4334 in Participants With Alzheimer's Clinical Syndrome (MK-4334-005) Phase 1
Active, not recruiting NCT05204940 - Longitudinal Observational Biomarker Study
Recruiting NCT02663531 - Retinal Neuro-vascular Coupling in Patients With Neurodegenerative Disease N/A
Recruiting NCT06150352 - Sleep Apnea, Neurocognitive Decline and Brain Imaging in Patients With Subjective or Mild Cognitive Impairment
Recruiting NCT03507192 - Effects of Muscle Relaxation on Cognitive Function in Patients With Mild Cognitive Impairment and Early Stage Dementia. N/A