Multi-component Exercise on Mild Cognitive Impairment In Elderly Population
Primary Purpose
Mild Cognitive Impairment
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Experimental group
Control group
Sponsored by

About this trial
This is an interventional treatment trial for Mild Cognitive Impairment focused on measuring Exercise, Mild Cognitive Impairment, Elderly Population
Eligibility Criteria
Inclusion Criteria:
- Both men and women
- Mini-Mental State Examination (MMSE) score 18- 23 (mild cognitive impairment)
Exclusion Criteria:
- Had current medical condition for which exercise is contraindicated
- Had neurodegenerative disease /stroke
- Oncologic patient with active treatment with chemotherapy
- Patient with arterial diseases in the past 12 months
Sites / Locations
- Riphah International University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Experimental group
Control group
Arm Description
Multi-component intervention
treadmill walk
Outcomes
Primary Outcome Measures
Mini mental state examination (MMSE)
Changes from the Baseline, Mini mental state examination (MMSE): used to screen for cognitive impairment in elderly. It is as 30-point questionnaire. The reliability of the MMSE, ranging from 0.76 to 0.90.
Trail making test (TMT) A & B
Changes from the Baseline, Trail making test (TMT) A & B: It is a test of visual attention and task switching. It provides information about visual search speed, speed of processing and executive function. The test reliability for TMT (A -B) is 0.82 and 0.93. Time will be measured in seconds
Montreal cognitive assessment (MoCA)
Changes from the Baseline, Montreal cognitive assessment (MoCA): it is used widely for screening cognitive impairment.The test re-test reliability for MOCA is 0.966. Scoring. MoCA scores range between 0 and 30. A score of 26 or over is considered to be normal. In a study, normal people scored an average of 27.4; people with mild cognitive impairment (MCI) scored an average of 22.1; people with Alzheimer's disease scored an average of 16.2.
Secondary Outcome Measures
Full Information
NCT ID
NCT03938051
First Posted
May 2, 2019
Last Updated
September 4, 2019
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT03938051
Brief Title
Multi-component Exercise on Mild Cognitive Impairment In Elderly Population
Official Title
Effects of Multicomponent Exercise on Mild Cognitive Impairment In Elderly Population ,a Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
January 15, 2019 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
July 12, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Participants will be randomized to exercise intervention and control groups, for 6 weeks. The participants will be examined for following test Mini mental state examination, Trail making test A and B, MOCA. The intervention will consist of twice weekly, 55- 60 minute exercise session for experimental group The participants of control group will receive 20 minutes treadmill walk thrice weekly. Participants will walk at constant pace with zero inclination such that a subjective rate of perceived of 5 to 7 points on the ten-point Borg scale will be reached. Assessment of both groups will be done on first session and on last session.
Detailed Description
Elderly, old person and senior citizen are all the terms generally used for geriatric population. According to WHO, most developed countries have accepted the chronological age of 65 years as definition of elderly or older population which cannot be applied to developing third world countries as the life expectancy is between 60 to 70 years. The United Nation agreed cutoff is 60+ years to refer to old age. Adding to difficulty of defining actual birth dates is often unknown in some areas because many people do not have official birth records.
Aging is characterized by gradual irreversible changes in structure and function of an individual that occur as a result of the passage of time. It is additionally subject to the developments by which general public understands maturity. It is associated with declines in different systems of body, resulting in an impaired capacity to perform daily activities placing a large economic burden on society. Life of the elderly is characterized by a high risk of multimorbidity accompanied by a high prevalence of cognitive impairment short of dementia. A decline in cognitive abilities, such as perception, reasoning, and memory, is part of the normal cognitive aging process. It is a process that is genetically defined and environmentally modulated. In fact, advancing age is the major risk factor for a number of chronic diseases in humans. A decrease in cognitive performance in older adults is predominant in most individuals. During next 40 years, it is anticipated that there will be an epidemic of dementia worldwide, with a 3- to 4-fold increase in the number of prevalent cases owing to longer life expectancies and demographic changes. Attention is turning toward identification of preclinical disease and development of treatments to prevent or delay the onset of dementia. Cognitive impairment is a health problem that almost concerns to every second elderly person.
There is of evidence from epidemiological studies, experimental trials, and basic neurosciences that suggesting that cognitive decline related to aging can be cut off by different intellectual activities which makes you less prone to cognitive problems faced at later ages. There is always a debate whether cognitive mental activities are more better or physical activity is better solution for these age related cognitive decline .Some studies showed that cognitive training is effective when cognitive skills are practiced.
Cognitive decline due to aging leads to functional limitation and disability which leaves the society with a huge economic burden. That is why, intervention and plan should be designed to lessen this economic burden furthermore maintain and control epidemics like dementia and other cognitive disorders. Physical activity has shown tremendous results in improving cognition function in healthy older adults and as well as in older adults affected with cognitive diseases and disorders. Evidence from epidemiological studies shows that physical activity of high levels and for longer follow-ups showed better results in decreasing the likelihood of developing cognitive impairments as compared to people with low levels of physical activity .Therefore, it is hypothesized that physical activity plays an important role in alleviating cognitive decline in older adults. Physical movement has been appeared to have an intense up regulating impact on neurogenesis and to result in increased concentration of brain derived neurotropic factor.
Despite of the beneficial effects observed in cognitive outcomes with aerobic exercise training in Previous studies aerobic exercise was associated with progress in neurocognitive functions in older adults whether cognitive impairment is present or not . A study conducted in 2012 reported significant improvements in memory domain and few other studies showed significant improvements in executive function after following aerobic training protocol. But there was lack of consistent evidence to show the beneficial effects of aerobic training on cognition in elderly population. Many other researchers focused on resistive training exercises for improving cognitive and memory functions.With advancement of time and technology newer exercise techniques and modalities have been developed to maximize functional capacities of older adults. In these days of development multi-component exercises is a new combination of training exercise in which aerobic, resistance training is combined with balance ,coordination, flexibility to decrease disability in older adults.Multi-component is the most effective approach in addressing functional capacity in frail older adults and limiting disability.Functional benefits of this exercise are well established ,however evidence is less consistent regarding cognitive gains associated with multi-component exercise training. A study reported that aerobic and resistance training combined has better gains in working memory as compared to aerobic training alone.
In the light of literature review studies were conducted to determine the effects of different types of physical activity on cognition of elderly people and in prevention of decreasing cognitive levels in elderly people. The impact of exercises including aerobic training, resistive training, aerobic training versus stretching, resistive training versus stretching, resistive training with no intervention were previously examined however, results were less clear and consistent.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
Keywords
Exercise, Mild Cognitive Impairment, Elderly Population
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Multi-component intervention
Arm Title
Control group
Arm Type
Experimental
Arm Description
treadmill walk
Intervention Type
Other
Intervention Name(s)
Experimental group
Intervention Description
Multicomponent intervention for twice weekly 55-60 minutes 6 weeks
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
20 minutes treadmill walk thrice weekly, 5-7 /10 subjective rate of perceived exertion
Primary Outcome Measure Information:
Title
Mini mental state examination (MMSE)
Description
Changes from the Baseline, Mini mental state examination (MMSE): used to screen for cognitive impairment in elderly. It is as 30-point questionnaire. The reliability of the MMSE, ranging from 0.76 to 0.90.
Time Frame
6 week
Title
Trail making test (TMT) A & B
Description
Changes from the Baseline, Trail making test (TMT) A & B: It is a test of visual attention and task switching. It provides information about visual search speed, speed of processing and executive function. The test reliability for TMT (A -B) is 0.82 and 0.93. Time will be measured in seconds
Time Frame
6 week
Title
Montreal cognitive assessment (MoCA)
Description
Changes from the Baseline, Montreal cognitive assessment (MoCA): it is used widely for screening cognitive impairment.The test re-test reliability for MOCA is 0.966. Scoring. MoCA scores range between 0 and 30. A score of 26 or over is considered to be normal. In a study, normal people scored an average of 27.4; people with mild cognitive impairment (MCI) scored an average of 22.1; people with Alzheimer's disease scored an average of 16.2.
Time Frame
6 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Both men and women
Mini-Mental State Examination (MMSE) score 18- 23 (mild cognitive impairment)
Exclusion Criteria:
Had current medical condition for which exercise is contraindicated
Had neurodegenerative disease /stroke
Oncologic patient with active treatment with chemotherapy
Patient with arterial diseases in the past 12 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Imran Amjad, PHD*
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Riphah International University
City
Islamabad
State/Province
Federal
ZIP/Postal Code
44000
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
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Multi-component Exercise on Mild Cognitive Impairment In Elderly Population
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