Multi-component Exercise on Mild Cognitive Impairment In Elderly Population

NCT03938051 | Completed DMC

• 1 other identifier: RiphahIU Hafsah Gul Khattak
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment

Keywords

Exercise; Mild Cognitive Impairment; Elderly Population

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

Experimental group

EXPERIMENTAL

Multi-component intervention

Other: Experimental group

Control group

EXPERIMENTAL

treadmill walk

Other: Control group

Interventions

Experimental group OTHER

Multicomponent intervention for twice weekly 55-60 minutes 6 weeks

Experimental group

Control group OTHER

20 minutes treadmill walk thrice weekly, 5-7 /10 subjective rate of perceived exertion

Control group

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Both men and women
• Mini-Mental State Examination (MMSE) score 18- 23 (mild cognitive impairment)

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Riphah International University

Islamabad, Federal, 44000, Pakistan

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Motor Activity

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Imran Amjad, PHD*

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2019
• First Posted: May 6, 2019
• Study Start: January 15, 2019
• Primary Completion: June 30, 2019
• Study Completion: July 12, 2019
• Last Updated: September 6, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)