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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03938051
Other study ID # RiphahIU Hafsah Gul Khattak
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 15, 2019
Est. completion date July 12, 2019

Study information

Verified date September 2019
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 51
Est. completion date July 12, 2019
Est. primary completion date June 30, 2019
Accepts healthy volunteers No
Gender All
Age group 55 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Experimental group
Multicomponent intervention for twice weekly 55-60 minutes 6 weeks
Control group
20 minutes treadmill walk thrice weekly, 5-7 /10 subjective rate of perceived exertion

Locations

Country Name City State
Pakistan Riphah International University Islamabad Federal

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 6 week
Primary 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 6 week
Primary 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. 6 week
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