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Trial of Aerobic Exercise Training in Stroke Survivors

Primary Purpose

Stroke, Insulin Resistance, Sedentary Lifestyle

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aerobic Exercise
Stretching
Sponsored by
Baltimore VA Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Exercise, Inflammation, Insulin Sensitivity

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Ischemic or hemorrhagic stroke greater than or equal to 6 months prior with stable residual hemiparetic gait deficits
  • Already completed all conventional inpatient and outpatient physical therapy
  • Adequate language and neurocognitive function to safely participate in exercise testing and training
  • Men or women ages 40-75 years
  • Body mass index between 20 to 50 kg/m2
  • Non-smoker, or history of no smoking for more than 5 years
  • Under the care of a primary care medical provider

Exclusion Criteria:

  • Already performing aerobic exercise 3 times a week
  • Increased alcohol consumption defined as greater than 2 oz. liquor or 8 oz. of wine or 24 oz. of beer per day
  • Cardiac history of:

    1. unstable angina
    2. recent (less than 3 months prior to study entry) myocardial infarction, congestive heart failure
    3. hemodynamically significant valvular dysfunction
  • Medical History:

    1. recent hospitalization (less than 3 months prior to study entry) for severe medical disease
    2. peripheral arterial disease with vascular claudication
    3. orthopedic or chronic pain condition restricting exercise
    4. pulmonary or renal failure
    5. active cancer
    6. untreated poorly controlled hypertension measured on at least 2 occasions (greater than 160/100)
    7. type I diabetes mellitus, insulin therapy, untreated and/or poorly controlled diabetes with fasting blood glucose of greater than 160
    8. smoking within the last 5 years
    9. allergy to lidocaine
    10. medications: heparin, warfarin, lovenox, beta-blockers, oral steroids
  • Neurological history of:

    1. dementia with Mini-Mental Status Score less than 23 (less than 17 if education level at or below 8th grade), and diagnostic confirmation by neurologist or psychiatrist
    2. severe receptive or global aphasia which confounds testing and training, operationally defined as unable to follow 2 point commands
    3. hemiparetic gait from a prior stroke preceding the index stroke defining eligibility (more than one stroke)
    4. neurologic disorder restricting exercise, such as Parkinsons Syndrome or myopathy
    5. untreated major depression
  • Adipose tissue and muscle biopsy exclusion criteria:

    1. anti-coagulation therapy with heparin, warfarin, or lovenox (anti-platelet therapy is permitted)
    2. bleeding disorder
    3. allergy to lidocaine

Sites / Locations

  • University of Maryland, VAMC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Aerobic Exercise

Stretch Control

Arm Description

Treadmill training

Stretching exercises

Outcomes

Primary Outcome Measures

VO2peak
maximal oxygen consumption during a treadmill test

Secondary Outcome Measures

Whole body insulin sensitivity
glucose utilization during a glucose clamp
Cytokines
circulating TNF alpha levels
Body fat
whole body percent fat
Muscle mass
whole body lean mass

Full Information

First Posted
April 30, 2009
Last Updated
October 10, 2018
Sponsor
Baltimore VA Medical Center
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT00891514
Brief Title
Trial of Aerobic Exercise Training in Stroke Survivors
Official Title
Aging, Inflammation and Exercise in Chronic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
September 1, 2009 (Actual)
Primary Completion Date
July 31, 2018 (Actual)
Study Completion Date
July 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baltimore VA Medical Center
Collaborators
National Institute on Aging (NIA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to examine the effects of treadmill training on inflammation in the skeletal muscle and adipose tissue, insulin action in the skeletal muscle, and whole body glucose metabolism in stroke survivors. The fundamental hypothesis of this study is that key inflammatory markers in adipose tissue and skeletal muscle are abnormal, skeletal muscle insulin signaling is impaired, and systemic insulin sensitivity is reduced in hemiparetic stroke patients and that these factors are modifiable and improved by exercise training in stroke patients.
Detailed Description
Many stroke survivors are sedentary and are at risk for the development of diabetes. We will study the interactions of adipose tissue and the paretic and non-paretic muscle inflammation, insulin signaling and action in hemiparetic stroke patients and the ability to employ exercise training to reverse these abnormalities in this ethnically diverse population. Participants aged 40-75 years with chronic stroke will be randomized to treadmill training versus stretch control group using a one-two-one blocked randomization on race (black vs. white), sex (male vs. female), and glucose tolerance status (normal vs. impaired and type 2 diabetes). Stroke occurs in over 780,000 persons each year in the U.S., the vast majority reported in persons older than 55 years of age. Following stroke, patients remain at continued high risk for recurrent stroke. Inflammatory processes lead to cardiovascular events/stroke and contribute to disease risk progression by impacting insulin resistance and the development of type 2 diabetes. Interventions that reduce inflammation and improve insulin sensitivity have important clinical implications, especially in the stroke population. Task-oriented treadmill training is utilized to improve cardiovascular fitness and functional mobility in hemiparetic stroke patients. Additionally, preliminary data indicates that progressive treadmill training in this population improves glucose tolerance.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Insulin Resistance, Sedentary Lifestyle
Keywords
Exercise, Inflammation, Insulin Sensitivity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
98 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aerobic Exercise
Arm Type
Experimental
Arm Description
Treadmill training
Arm Title
Stretch Control
Arm Type
Active Comparator
Arm Description
Stretching exercises
Intervention Type
Behavioral
Intervention Name(s)
Aerobic Exercise
Intervention Description
Treadmill training- begins at 15 minutes total duration at 40-50% maximal heart rate reserve 3 times per week, increasing to 60-70% maximal heart rate reserve for 45-60 minutes for 6 months
Intervention Type
Behavioral
Intervention Name(s)
Stretching
Intervention Description
Stretching, balance exercises, and components of conventional physical therapy-- begins at 15 minutes and progresses to 45 minutes for 6 months
Primary Outcome Measure Information:
Title
VO2peak
Description
maximal oxygen consumption during a treadmill test
Time Frame
Baseline and 6 months
Secondary Outcome Measure Information:
Title
Whole body insulin sensitivity
Description
glucose utilization during a glucose clamp
Time Frame
Baseline and 6 months
Title
Cytokines
Description
circulating TNF alpha levels
Time Frame
Baseline and 6 months
Title
Body fat
Description
whole body percent fat
Time Frame
Baseline and 6 months
Title
Muscle mass
Description
whole body lean mass
Time Frame
Baseline and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ischemic or hemorrhagic stroke greater than or equal to 6 months prior with stable residual hemiparetic gait deficits Already completed all conventional inpatient and outpatient physical therapy Adequate language and neurocognitive function to safely participate in exercise testing and training Men or women ages 40-75 years Body mass index between 20 to 50 kg/m2 Non-smoker, or history of no smoking for more than 5 years Under the care of a primary care medical provider Exclusion Criteria: Already performing aerobic exercise 3 times a week Increased alcohol consumption defined as greater than 2 oz. liquor or 8 oz. of wine or 24 oz. of beer per day Cardiac history of: unstable angina recent (less than 3 months prior to study entry) myocardial infarction, congestive heart failure hemodynamically significant valvular dysfunction Medical History: recent hospitalization (less than 3 months prior to study entry) for severe medical disease peripheral arterial disease with vascular claudication orthopedic or chronic pain condition restricting exercise pulmonary or renal failure active cancer untreated poorly controlled hypertension measured on at least 2 occasions (greater than 160/100) type I diabetes mellitus, insulin therapy, untreated and/or poorly controlled diabetes with fasting blood glucose of greater than 160 smoking within the last 5 years allergy to lidocaine medications: heparin, warfarin, lovenox, beta-blockers, oral steroids Neurological history of: dementia with Mini-Mental Status Score less than 23 (less than 17 if education level at or below 8th grade), and diagnostic confirmation by neurologist or psychiatrist severe receptive or global aphasia which confounds testing and training, operationally defined as unable to follow 2 point commands hemiparetic gait from a prior stroke preceding the index stroke defining eligibility (more than one stroke) neurologic disorder restricting exercise, such as Parkinsons Syndrome or myopathy untreated major depression Adipose tissue and muscle biopsy exclusion criteria: anti-coagulation therapy with heparin, warfarin, or lovenox (anti-platelet therapy is permitted) bleeding disorder allergy to lidocaine
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alice S. Ryan, PhD
Organizational Affiliation
University of Maryland, VA Research Service
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Charlene Hafer-Macko, MD
Organizational Affiliation
University of Maryland, VA Research Service, Department of Neurology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Maryland, VAMC
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
20705
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
12474173
Citation
Ryan AS, Dobrovolny CL, Smith GV, Silver KH, Macko RF. Hemiparetic muscle atrophy and increased intramuscular fat in stroke patients. Arch Phys Med Rehabil. 2002 Dec;83(12):1703-7. doi: 10.1053/apmr.2002.36399.
Results Reference
background
PubMed Identifier
16109906
Citation
Hafer-Macko CE, Yu S, Ryan AS, Ivey FM, Macko RF. Elevated tumor necrosis factor-alpha in skeletal muscle after stroke. Stroke. 2005 Sep;36(9):2021-3. doi: 10.1161/01.STR.0000177878.33559.fe. Epub 2005 Aug 18.
Results Reference
background
PubMed Identifier
17702957
Citation
Ivey FM, Ryan AS, Hafer-Macko CE, Goldberg AP, Macko RF. Treadmill aerobic training improves glucose tolerance and indices of insulin sensitivity in disabled stroke survivors: a preliminary report. Stroke. 2007 Oct;38(10):2752-8. doi: 10.1161/STROKEAHA.107.490391. Epub 2007 Aug 16.
Results Reference
background
PubMed Identifier
35192798
Citation
Ryan AS, Novitskaya M, Treuth AL. Predictive Equations Overestimate Resting Metabolic Rate in Survivors of Chronic Stroke. Arch Phys Med Rehabil. 2022 Jul;103(7):1352-1359. doi: 10.1016/j.apmr.2022.01.155. Epub 2022 Feb 19.
Results Reference
derived
PubMed Identifier
27322733
Citation
Serra MC, Balraj E, DiSanzo BL, Ivey FM, Hafer-Macko CE, Treuth MS, Ryan AS. Validating accelerometry as a measure of physical activity and energy expenditure in chronic stroke. Top Stroke Rehabil. 2017 Jan;24(1):18-23. doi: 10.1080/10749357.2016.1183866. Epub 2016 Jun 20.
Results Reference
derived

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Trial of Aerobic Exercise Training in Stroke Survivors

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