Back to results

Mild Cognitive Impairment, Buddy Supported Exercise/ My Buddy Study

Primary Purpose

Mild Cognitive Impairment, Cognitive Disorders

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

5-month aerobic exercise intervention

About this trial

This is an interventional prevention trial for Mild Cognitive Impairment focused on measuring mild cognitive impairment, cognitive disorders, exercise

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Participants:

Age 60 and up
Montreal Cognitive Assessment (MoCA) score 16-28
CDR= 0.5 with memory box at least 0.5.
Have a person (study partner) who can answer questions about their cognition for the CDR, FAQ and NPI-Q. This should be the same person who will come to all clinic visits whenever possible. This person can be called to answer these questions if unable to come into the clinic.
Sedentary for past 3 months (< 45 min /wk of exercise, including walking)
Able to walk 400 meters in < 15 min without assistance
Willing to exercise 4 days a week at Body Check at CompRehab
Physician approval for participation in the exercise intervention

Buddy:

No report of memory problem
MoCA score > 24 if > HS education; > 23 if 9-12 years; > 22 if ,< 9 years of education

Exclusion Criteria:

Due to Cognitive Confounders:

Uncontrolled depression (PHQ-9 > 10)
Schizophrenia or bipolar disorder
Parkinson's disease
Hachinski ischemic index > 4
Daily use of highly anticholinergic medications (such as amitriptyline, diphenhydramine, scopolamine, etc) or benzodiazepines
Use of stable dose of Cholinesterase inhibitors will be permitted. Must be on a stable dose for 4 weeks.
Non-English speaking (as we are unable to administer the cognitive tests in languages other than English for this pilot)
Vitamin B12 deficiency
Uncontrolled hypothyroidism as measured by TSH blood test

Due to increased risk of or low likelihood of compliance with the exercise program:

Active ischemic heart disease or angina
symptomatic heart failure
stroke
screening blood pressure SBP > 170 or < 90; DBP > 100 or < 45
Parkinson's disease or other neurologic disorder that might make exercise on a treadmill or bike unsafe
Current or planned treatment for cancer
peripheral artery disease that limits exercise capacity
Severe respiratory-disease (e.g., COPD) that limits exercise capacity
Severe arthritis that limits exercise capacity
Serious conduction disorder, uncontrolled arrhythmia, or new Q waves or ST-segment depressions (> 3 mm) on ECG
Severe anemia (Hgb < 8)
Diagnosis of Diabetes and on medication
Drinks more than 14 alcoholic drinks per week
Dependent on a cane, walker or other device that would inhibit then from using a treadmill

Sites / Locations

Wake Forest Baptist Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Buddy

Non Buddy

Arm Description

Participant will be assigned a buddy that will meet with them at the gym for each of their exercise sessions. This person will serve as a source of support and motivation for them and will also help them remember and stick to the goals set for you. This person will also help them maintain their exercise logs and ensure they are correct. The buddy will not be exercising with them, but will just be there with them while you exercise.

Participants will not be assigned a buddy (and are not allowed to bring someone with them as a buddy). They will be asked to exercise on their own and remember the goals set for them. They will also be responsible for filling out their own exercise logs and ensuring they are correct.

Outcomes

Primary Outcome Measures

Adherence (number of sessions attended and exercise duration in targeted heart rate zone)

This is a pilot study with the principle outcome measures related to recruitment and retention of participants with MCI and buddies and adherence to the protocol. We are specifically interested in: Time to recruit 20 participants % of participants who identify their own buddy Number of community volunteers to be buddies over the recruitment period Retention at 3- and 5- months Adherence (number of exercise sessions attended, exercise duration in targeted HR zone)

Secondary Outcome Measures

Change in score on Digit Symbol Coding Test

Change in 400m walk time (from randomization to 5 months)

Change in Trail Making Test part B score

change in memory, measured by Rey AVLT delayed recall score, at 5 months

Full Information

NCT ID

NCT01561820

First Posted

March 8, 2012

Last Updated

September 25, 2019

Sponsor

Wake Forest University

1. Study Identification

Unique Protocol Identification Number

NCT01561820

Brief Title

Mild Cognitive Impairment, Buddy Supported Exercise/ My Buddy Study

Official Title

Community-based, Buddy-supported Exercise in Patients With MCI: a Pilot Trial

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Completed

Study Start Date

November 2011 (undefined)

Primary Completion Date

December 2012 (Actual)

Study Completion Date

December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Wake Forest University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This is a small pilot trial of a 5 month aerobic exercise intervention in participants with MCI (n=20) to begin to compare the effects of randomization to use an exercise buddy or to exercise without an assigned buddy. The investigators hypothesize that participants with MCI who exercise with a buddy will have higher adherence to the protocol and greater improvement in 400 meter walk time.

Detailed Description

The overall objective of this pilot study is to determine feasibility and gather data that will inform the design of a larger, multicenter, randomized, controlled trial. Specifically, the investigators aim to: 2.1 Determine the feasibility of recruiting persons with MCI and a buddy for an exercise intervention. - For MCI participants who do not identify a buddy, the investigators will determine the interest and feasibility of recruiting volunteers from the community to be an exercise buddy. 2.2 Determine the effects of having an exercise buddy on: adherence to the protocol 400 meter walk time, an objective measure of improved physical fitness retention and satisfaction for both participant with MCI and buddy 2.3 Establish a scientific partnership with a community based exercise facility.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mild Cognitive Impairment, Cognitive Disorders

Keywords

mild cognitive impairment, cognitive disorders, exercise

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Buddy

Arm Type

Active Comparator

Arm Description

Arm Title

Non Buddy

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

5-month aerobic exercise intervention

Intervention Description

The 5-month aerobic exercise intervention is in accordance with the American Heart Association and American College of Sports Medicine physical activity recommendation for optimizing cardiovascular fitness in older adults.Exercise will consist primarily of walking on the treadmill.The goal of the program will be for participants to exercise at a moderate- to high-intensity, defined as 65-80% (ACSM guidelines) of heart rate reserve (HRR), for 30 minutes, 4 days per week.The duration of exercise will progress from 15-20 mins at 50% HRR the 1st week to 30 mins at 65-80% HRR by the end of the 6th week and thereafter.At the start of each session, exercise intensity will be gradually increased to 50% HRR(0.5[HRmax-HRrest]+HRrest)during a 10minute warmup period,and then to the individualized target heart rate training zone for the next 25-30 minutes.Participants will wear a digital heart rate monitoring device for the duration of the training session.

Primary Outcome Measure Information:

Title

Adherence (number of sessions attended and exercise duration in targeted heart rate zone)

Description

Time Frame

4 times a week for 5 months (each exercise session)

Secondary Outcome Measure Information:

Title

Change in score on Digit Symbol Coding Test

Time Frame

Baseline 3 months and 5 months

Title

Change in 400m walk time (from randomization to 5 months)

Time Frame

Baseline, 3 months and 5 months

Title

Change in Trail Making Test part B score

Time Frame

Baseline and 5 months

Title

change in memory, measured by Rey AVLT delayed recall score, at 5 months

Time Frame

baseline and 5 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Participants: Age 60 and up Montreal Cognitive Assessment (MoCA) score 16-28 CDR= 0.5 with memory box at least 0.5. Have a person (study partner) who can answer questions about their cognition for the CDR, FAQ and NPI-Q. This should be the same person who will come to all clinic visits whenever possible. This person can be called to answer these questions if unable to come into the clinic. Sedentary for past 3 months (< 45 min /wk of exercise, including walking) Able to walk 400 meters in < 15 min without assistance Willing to exercise 4 days a week at Body Check at CompRehab Physician approval for participation in the exercise intervention Buddy: No report of memory problem MoCA score > 24 if > HS education; > 23 if 9-12 years; > 22 if ,< 9 years of education Exclusion Criteria: Due to Cognitive Confounders: Uncontrolled depression (PHQ-9 > 10) Schizophrenia or bipolar disorder Parkinson's disease Hachinski ischemic index > 4 Daily use of highly anticholinergic medications (such as amitriptyline, diphenhydramine, scopolamine, etc) or benzodiazepines Use of stable dose of Cholinesterase inhibitors will be permitted. Must be on a stable dose for 4 weeks. Non-English speaking (as we are unable to administer the cognitive tests in languages other than English for this pilot) Vitamin B12 deficiency Uncontrolled hypothyroidism as measured by TSH blood test Due to increased risk of or low likelihood of compliance with the exercise program: Active ischemic heart disease or angina symptomatic heart failure stroke screening blood pressure SBP > 170 or < 90; DBP > 100 or < 45 Parkinson's disease or other neurologic disorder that might make exercise on a treadmill or bike unsafe Current or planned treatment for cancer peripheral artery disease that limits exercise capacity Severe respiratory-disease (e.g., COPD) that limits exercise capacity Severe arthritis that limits exercise capacity Serious conduction disorder, uncontrolled arrhythmia, or new Q waves or ST-segment depressions (> 3 mm) on ECG Severe anemia (Hgb < 8) Diagnosis of Diabetes and on medication Drinks more than 14 alcoholic drinks per week Dependent on a cane, walker or other device that would inhibit then from using a treadmill

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Laura Baker, Ph.D.

Organizational Affiliation

Wake Forest University Health Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

Wake Forest Baptist Health

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27157

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Mild Cognitive Impairment, Buddy Supported Exercise/ My Buddy Study

We'll reach out to this number within 24 hrs