Mild Cognitive ImpairmentNCT01561820
Mild Cognitive Impairment, Buddy Supported Exercise/ My Buddy Study
A study testing 5-month aerobic exercise intervention in people with Mild Cognitive Impairment and Cognitive Disorders, run by Wake Forest University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Mild Cognitive Impairment, Cognitive Disorders
- What is being tested?
- 5-month aerobic exercise intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Dec 2012
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157
About this study
Official title: Community-based, Buddy-supported Exercise in Patients With MCI: a Pilot Trial
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.
Read the 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.
- Conditions
- Mild Cognitive Impairment, Cognitive Disorders
- Being tested
- 5-month aerobic exercise intervention
- Keywords
- mild cognitive impairment, cognitive disorders, exercise
- 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.
5-month aerobic exercise interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Buddy | Active comparator | 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. Receives: Behavioral: 5-month aerobic exercise intervention |
| Non Buddy | Placebo comparator | 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. Receives: Behavioral: 5-month aerobic exercise intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 4 times a week for 5 months (each exercise session)
Secondary outcomes (4)
Change in score on Digit Symbol Coding Test
Measured: Baseline 3 months and 5 months
Change in 400m walk time (from randomization to 5 months)
Measured: Baseline, 3 months and 5 months
Change in Trail Making Test part B score
Measured: Baseline and 5 months
change in memory, measured by Rey AVLT delayed recall score, at 5 months
Measured: baseline and 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2012 (estimated)
- Study startNov 2011
- Primary completionDec 2012
- Study completionDec 2012
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura Baker, Ph.D., Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01561820
- Sponsor's protocol ID
- IRB00018495
- Status last verified
- Sep 2019
- First submitted
- 8 Mar 2012
- Last updated
- 26 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-based, Buddy-supported Exercise in Patients With MCI: a Pilot Trial
- ClinicalTrials.gov ID
- NCT01561820
- Acronym / sponsor ID
- IRB00018495
- Conditions
- Mild Cognitive Impairment, Cognitive Disorders
- Keywords
- mild cognitive impairment, cognitive disorders, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Wake Forest UniversityUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 23 Mar 2012 (estimated)
- 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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Buddy | Active comparator | Behavioral: 5-month aerobic exercise interventionParticipant 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. |
| Non Buddy | Placebo comparator | Behavioral: 5-month aerobic exercise interventionParticipants 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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)
Key exclusion criteria (25 listed)
- 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
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 |
|---|---|---|
| 5-month aerobic exercise interventionThe 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. | Behavioural | Buddy, Non Buddy |
Primary outcome
Adherence (number of sessions attended and exercise duration in targeted heart rate zone)
Time frame: 4 times a week for 5 months (each exercise session)
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)
4 secondary outcomes
Change in score on Digit Symbol Coding Test
Time frame: Baseline 3 months and 5 months
Change in 400m walk time (from randomization to 5 months)
Time frame: Baseline, 3 months and 5 months
Change in Trail Making Test part B score
Time frame: Baseline and 5 months
change in memory, measured by Rey AVLT delayed recall score, at 5 months
Time frame: baseline and 5 months
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 26 Sep 2019.
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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.
Laura Baker, Ph.D. principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 5-month aerobic exercise intervention in people with Mild Cognitive Impairment and Cognitive Disorders, run by Wake Forest University at 1 site in United States.
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 12 inclusion and 25 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 26 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 United States. 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. Some participants in this study may receive a placebo. 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?
Adherence (number of sessions attended and exercise duration in targeted heart rate zone) (time frame: 4 times a week for 5 months (each exercise session)). 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 26 Sep 2019.