NCT02626442

Brief Summary

The risk of stroke and vascular dementia is high in individuals who have had a prior stroke or TIA, and in those who have vascular disease risk factors, such as high blood pressure, abnormal cholesterol, diabetes or pre-diabetes. These vascular risk factors can improve with exercise. This study will examine the impact of a 6 month, low intensity group exercise class on fitness, walking, balance, and brain health. This study will also collect fitness, walking, balance, and brain health outcome measures at baseline and post all other MERCE exercise and robotics interventions.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Jul 2013

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

November 18, 2015

Completed
22 days until next milestone

First Posted

Study publicly available on registry

December 10, 2015

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

November 1, 2016

Status Verified

October 1, 2016

Enrollment Period

6.5 years

First QC Date

November 18, 2015

Last Update Submit

October 28, 2016

Conditions

StrokeCardiovascular Risk FactorsTransient Ischemic Attack (TIA)

Keywords

CognitionExercise

Outcome Measures

Primary Outcomes (4)

  • Change from Baseline in executive function

    Measured by cognitive battery

    6 months

  • Change from baseline in cortical thickness

    Measured during brain MRI

    6 month

  • Change from baseline in EEG

    EEG will be performed during tasks

    6 month

  • Change from baseline in hippocampal volume

    Measured during brain MRI

    6 month

Study Arms (2)

Group Exercise Class

EXPERIMENTAL

6 month group balance/exercise class, three days a week - up to one hour. Exercise program includes walking around a track, bodyweight/balance exercises, and an obstacle course.

Other: Exercise

Testing

NO INTERVENTION

Subjects enrolled in other MERCE exercise and robotics interventions will receive balance/walking tests, MRI with famous name recognition task, and cognitive testing pre and post their intervention.

Interventions

ExerciseOTHER

6 month group exercise class

Group Exercise Class

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adequate language and neurocognitive function to participate in testing and training and to give adequate informed consent
  • Able to rise from a chair unaided
  • Completion of all regular post-stroke physical therapy (if applicable)
  • Able to walk 30 feet without human assistance

You may not qualify if:

  • Clinical history of
  • unstable angina
  • recent (\< 3 months) myocardial infarction or congestive heart failure (NYHA category II)
  • hemodynamically significant valvular dysfunction
  • peripheral arterial obstructive disorder with claudication
  • major orthopedic, chronic pain, or non-stroke neuromuscular disorders restricting exercise
  • pulmonary or renal failure
  • poorly controlled hypertension (\>190/110), measured on at least two separate occasions
  • recent hospitalization for severe disease or surgery
  • severe or global receptive aphasia which confounds reliable testing and training
  • Other medical condition precluding patient participation in this study as per medical judgment of study team
  • Untreated major depression
  • Pregnancy
  • Alcohol consumption \> 3 oz. liquor, or 3 x 4 oz glasses of wine, or 3 x 12 oz. beers per day, by self-report
  • Dementia and other major cognitive deficits (based upon clinical evaluation)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baltimore VA Medical Center

Baltimore, Maryland, 21201, United States

RECRUITING

MeSH Terms

Conditions

StrokeIschemic Attack, TransientMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBrain IschemiaBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Emily Byrne, BS

    Baltimore VA Medical Center

    STUDY DIRECTOR

Central Study Contacts

Rich Macko, MD

CONTACT

410-605-7000rmacko@grecc.umaryland.edu

Charlene Hafer-Macko, MD

CONTACT

410-605-7000cmacko@grecc.umaryland.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Director of Research for the GRECC

Study Record Dates

First Submitted

November 18, 2015

First Posted

December 10, 2015

Study Start

July 1, 2013

Primary Completion

January 1, 2020

Study Completion

January 1, 2025

Last Updated

November 1, 2016

Record last verified: 2016-10

Locations

US(1)