NCT00891514

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
98

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Sep 2009

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

April 30, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 1, 2009

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
8.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2018

Completed
Last Updated

October 11, 2018

Status Verified

October 1, 2018

Enrollment Period

8.9 years

First QC Date

April 30, 2009

Last Update Submit

October 10, 2018

Conditions

StrokeInsulin ResistanceSedentary Lifestyle

Keywords

ExerciseInflammationInsulin Sensitivity

Outcome Measures

Primary Outcomes (1)

  • VO2peak

    maximal oxygen consumption during a treadmill test

    Baseline and 6 months

Secondary Outcomes (4)

  • Whole body insulin sensitivity

    Baseline and 6 months

  • Cytokines

    Baseline and 6 months

  • Body fat

    Baseline and 6 months

  • Muscle mass

    Baseline and 6 months

Study Arms (2)

Aerobic Exercise

EXPERIMENTAL

Treadmill training

Behavioral: Aerobic Exercise

Stretch Control

ACTIVE COMPARATOR

Stretching exercises

Behavioral: Stretching

Interventions

Aerobic ExerciseBEHAVIORAL

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

Aerobic Exercise
StretchingBEHAVIORAL

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

Stretch Control

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Maryland, VAMC

Baltimore, Maryland, 20705, United States

Location

Related Publications (5)

  • 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.

    PMID: 12474173BACKGROUND

  • 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.

    PMID: 16109906BACKGROUND

  • 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.

    PMID: 17702957BACKGROUND

  • 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.

    PMID: 35192798DERIVED

  • 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.

    PMID: 27322733DERIVED

MeSH Terms

Conditions

StrokeInsulin ResistanceSedentary BehaviorMotor ActivityInflammation

Interventions

Exercise

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesBehaviorPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Alice S. Ryan, PhD

    University of Maryland, VA Research Service

    PRINCIPAL INVESTIGATOR

  • Charlene Hafer-Macko, MD

    University of Maryland, VA Research Service, Department of Neurology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 30, 2009

First Posted

May 1, 2009

Study Start

September 1, 2009

Primary Completion

July 31, 2018

Study Completion

July 31, 2018

Last Updated

October 11, 2018

Record last verified: 2018-10

Locations

US(1)