Mild Cognitive ImpairmentNCT03938051
Multi-component Exercise on Mild Cognitive Impairment In Elderly Population
A study testing Experimental group in people with Mild Cognitive Impairment, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Experimental group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jan 2019to 12 Jul 2019
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both men and women
- Mini-Mental State Examination (MMSE) score 18- 23 (mild cognitive impairment)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Multicomponent Exercise on Mild Cognitive Impairment In Elderly Population ,a Randomized Control Trial
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.
Read the 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.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Experimental group, Control group
- Keywords
- Exercise, Mild Cognitive Impairment, Elderly Population
- Medical subject headings
- Cognitive Dysfunction, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental groupOther
Multicomponent intervention for twice weekly 55-60 minutes 6 weeks
Control groupOther
20 minutes treadmill walk thrice weekly, 5-7 /10 subjective rate of perceived exertion
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Multi-component intervention Receives: Other: Experimental group |
| Control group | Experimental | treadmill walk Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 week
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
Measured: 6 week
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.
Measured: 6 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2019
- Study start15 Jan 2019
- Primary completion30 Jun 2019
- Study completion12 Jul 2019
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.
- 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
- Investigator
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Imran Amjad, PHD*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03938051
- Sponsor's protocol ID
- RiphahIU Hafsah Gul Khattak
- Status last verified
- Sep 2019
- First submitted
- 2 May 2019
- Last updated
- 6 Sep 2019
- 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 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Multicomponent Exercise on Mild Cognitive Impairment In Elderly Population ,a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT03938051
- Acronym / sponsor ID
- RiphahIU Hafsah Gul Khattak
- Conditions
- Mild Cognitive Impairment
- Keywords
- Exercise, Mild Cognitive Impairment, Elderly Population
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 12 Jul 2019 (actual)
- First posted
- 6 May 2019 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Experimental groupMulti-component intervention |
| Control group | Experimental | Other: Control grouptreadmill walk |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Both men and women
- Mini-Mental State Examination (MMSE) score 18- 23 (mild cognitive impairment)
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Experimental groupMulticomponent intervention for twice weekly 55-60 minutes 6 weeks | Other | Experimental group |
| Control group20 minutes treadmill walk thrice weekly, 5-7 /10 subjective rate of perceived exertion | Other | Control group |
Primary outcome
Mini mental state examination (MMSE)
Time frame: 6 week
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
Time frame: 6 week
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)
Time frame: 6 week
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.
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 6 Sep 2019.
- 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.
Imran Amjad, PHD* principal investigator
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 Experimental group 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 2 inclusion and 4 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 6 Sep 2019. 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?
Mini mental state examination (MMSE) (time frame: 6 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 6 Sep 2019; AzTrials last refreshed its copy on 30 Oct 2026.