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StrokeNCT00891514

Trial of Aerobic Exercise Training in Stroke Survivors

A study testing Aerobic Exercise and Stretching in people with Stroke and Insulin Resistance, run by Baltimore VA Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 75 years
Conditions the study is for
Stroke, Insulin Resistance, Sedentary Lifestyle
What is being tested?
Aerobic Exercise and Stretching
Could I receive a placebo?
No, everyone receives an active treatment
How many people
98 participants
Where
1 siteUnited States
Study dates
1 Sep 2009to 31 Jul 2018
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 40 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 27Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Maryland, VAMC

    Baltimore, Maryland, 20705

Other trials in United States

About this study

Official title: Aging, Inflammation and Exercise in Chronic Stroke

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.

Read the 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.

Being tested
Aerobic Exercise, Stretching
Keywords
Exercise, Inflammation, Insulin Sensitivity
Medical subject headings
Stroke, Insulin Resistance, Sedentary Behavior, Motor Activity, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Aerobic ExerciseBehavioural

    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

  • StretchingBehavioural

    Stretching, balance exercises, and components of conventional physical therapy-- begins at 15 minutes and progresses to 45 minutes for 6 months

Study groups in NCT00891514
Study groupRoleWhat they receive
Aerobic ExerciseExperimentalTreadmill training
Receives: Behavioral: Aerobic Exercise
Stretch ControlActive comparatorStretching exercises
Receives: Behavioral: Stretching

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. VO2peak

    maximal oxygen consumption during a treadmill test

    Measured: Baseline and 6 months

Secondary outcomes (4)

  1. Whole body insulin sensitivity

    glucose utilization during a glucose clamp

    Measured: Baseline and 6 months

  2. Cytokines

    circulating TNF alpha levels

    Measured: Baseline and 6 months

  3. Body fat

    whole body percent fat

    Measured: Baseline and 6 months

  4. Muscle mass

    whole body lean mass

    Measured: Baseline and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2009 (estimated)
  2. Study start1 Sep 2009
  3. Primary completion31 Jul 2018
  4. Study completion31 Jul 2018

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
98 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00891514
Sponsor's protocol ID
AG0118
Other IDs
R01AG030075
Status last verified
Oct 2018
First submitted
30 Apr 2009
Last updated
11 Oct 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 12474173

  • 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.

    PubMed 16109906

  • 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.

    PubMed 17702957

  • 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.

    PubMed 35192798

  • 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.

    PubMed 27322733

Questions about this trial

What is this clinical trial studying?

A study testing Aerobic Exercise and Stretching in people with Stroke and Insulin Resistance, run by Baltimore VA Medical Center 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 7 inclusion and 27 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 11 Oct 2018. 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. 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?

VO2peak (time frame: Baseline and 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00891514, which also lists 5 linked publications.

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 11 Oct 2018.

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