Mild Cognitive ImpairmentNCT06308237
Effects of Resisted Versus Balance Exercises on Cognitive And Motor Function In Patients With Mild Cognitive Impairment
A study testing RESISTED EXERCISES and BALANCE EXERCISES in people with Mild Cognitive Impairment, run by Riphah International University at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 60 to 75 years
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- RESISTED EXERCISES and BALANCE EXERCISES
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 sitePakistan
- Study dates
- 25 Feb 2024to 10 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Riphah International University
Lahore, Punjab Province, 54660
About this study
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.
Read the 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.
- Conditions
- Mild Cognitive Impairment
- Being tested
- RESISTED EXERCISES, BALANCE EXERCISES
- Keywords
- Cognition, Motor control, Randomized clinical trial
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RESISTED EXERCISESOther
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 EXERCISESOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Other: BALANCE EXERCISES |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 16th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start25 Feb 2024
- Primary completion10 Jul 2024
- Study completion10 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Kashif, Phd-PT, Study chair, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06308237
- Sponsor's protocol ID
- REC/RCR&AHS/23/0293
- Status last verified
- Oct 2024
- First submitted
- 4 Mar 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Resisted Versus Balance Exercises on Cognitive And Motor Function In Patients With Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT06308237
- Acronym / sponsor ID
- REC/RCR&AHS/23/0293
- Conditions
- Mild Cognitive Impairment
- Keywords
- Cognition, Motor control, Randomized clinical trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 25 Feb 2024 (actual)
- Primary completion
- 10 Jul 2024 (actual)
- Study completion
- 10 Jul 2024 (actual)
- First posted
- 13 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GROUP A (RESISTED EXERCISES) | Experimental | Other: RESISTED EXERCISESGroup 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). |
| GROUP B (BALANCE EXERCISES) | Experimental | Other: BALANCE EXERCISESGroup 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). |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RESISTED EXERCISESPatients 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. | Other | GROUP A (RESISTED EXERCISES) |
| BALANCE EXERCISESStatic 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. | Other | GROUP B (BALANCE EXERCISES) |
Primary outcome
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
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muhammad Kashif, Phd-PT study chair
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RESISTED EXERCISES and BALANCE EXERCISES in people with Mild Cognitive Impairment, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MoCA (Montreal Cognitive Assessment ) (time frame: 14th week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.