Skeletal Muscle Properties and the Metabolic Cost of Walking Post-stroke

This study has been completed.
Sponsor:
Collaborator:
Medical University of South Carolina
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00721357
First received: July 21, 2008
Last updated: July 29, 2015
Last verified: July 2015
  Purpose

Of the ~700,000 persons who suffer a stroke each year, only 50% recover the ability to perform unlimited community walking. One mechanism contributing to locomotor dysfunction post-stroke is an increased metabolic cost of walking relative to neurologically healthy individuals 2-4. This increased cost likely limits the amount of walking performed, which further reduces functional capacity, thus contributing to long-term spiral of disability and decreased quality of life in these persons. In addition to increased metabolic cost, increased estimates of mechanical work are also characteristic of hemiparetic walking 2,29. Interestingly, although estimates of mechanical work reflect work done by locomotor muscles, little is known about the impact that peripheral muscle properties have on estimates of mechanical work. Furthermore, questions concerning how these properties relate to the increased metabolic cost of walking remain unanswered. The short-term objective and purpose of the proposed research is to determine the extent to which peripheral muscle characteristics, as well as estimates of muscle mechanical energy expenditure (MMEE), relate to the metabolic cost of walking post-stroke.


Condition Intervention Phase
Stroke
Behavioral: Treadmill walking
Other: Magnetic resonance spectroscopy
Phase 2

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Skeletal Muscle Properties and the Metabolic Cost of Walking Post-Stroke

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Oxygen Consumption During Walking [ Time Frame: within one week of enrollment ] [ Designated as safety issue: No ]
    Amount of oxygen consumed during walking at self-selected speed normalized to speed


Secondary Outcome Measures:
  • Muscle Mechanical Energy Expenditure [ Time Frame: one time measure ] [ Designated as safety issue: No ]
    mechanical work done by lower extremity joints

  • Magnetic Resonance Spectroscopy of Muscle Metabolic Properties [ Time Frame: within one week of enrollment ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   None Retained

None retained


Enrollment: 30
Study Start Date: August 2008
Study Completion Date: September 2013
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Stroke
Stroke subjects
Behavioral: Treadmill walking
Subjects will perform treadmill walking at a self-selected velocity
Other: Magnetic resonance spectroscopy
Muscle oxidative capacity will be assessed via Magnetic resonance spectroscopy (31P-MRS)
Control
neurologically healthy subjects
Behavioral: Treadmill walking
Subjects will perform treadmill walking at a self-selected velocity
Other: Magnetic resonance spectroscopy
Muscle oxidative capacity will be assessed via Magnetic resonance spectroscopy (31P-MRS)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

community sample

Criteria

Inclusion Criteria:

  • age 18-80;
  • stroke within past 6 months - 5 years;
  • residual paresis in the lower extremity (LE) (Fugl-Meyer motor score <34);
  • ability to sit unsupported for 30 sec;
  • ability to walk at least 10 ft with maximum 1 person assist;
  • self selected 10 meter gait speed < 0.8 m/s; and
  • provision of informed consent.

Exclusion Criteria:

  • Unable to ambulate at least 150 feet prior to stroke, or experienced intermittent claudication while walking < 200 meters;
  • history of congestive heart failure, unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living;
  • History of chronic obstructive pulmonary disease or oxygen dependence;
  • Preexisting neurological disorders, dementia or previous stroke;
  • History of major head trauma;
  • Legal blindness or severe visual impairment;
  • history of significant psychiatric illness;
  • Life expectancy <1 yr;
  • Severe arthritis or orthopedic problems that limit passive range of motion (ROM);
  • post-stroke depression (PHQ-9 10);
  • History of deep vein thrombosis (DVT) or pulmonary embolism within 6 months;
  • Uncontrolled diabetes with recent weight loss, diabetic coma, or frequent insulin reactions;
  • Severe hypertension with systolic >200 mmHg and diastolic >110 mmHg at rest;
  • Previous or current enrollment in a clinical trial to enhance motor recovery;
  • Presence of non-magnetic resonance (MR) compatible implants or devices, pregnancy or severe claustrophobia.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00721357

Locations
United States, South Carolina
Ralph H. Johnson VA Medical Center, Charleston, SC
Charleston, South Carolina, United States, 29401-5799
Sponsors and Collaborators
Medical University of South Carolina
Investigators
Principal Investigator: Chris M. Gregory, PhD Ralph H. Johnson VA Medical Center, Charleston, SC
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00721357     History of Changes
Other Study ID Numbers: B6341-W
Study First Received: July 21, 2008
Results First Received: January 8, 2015
Last Updated: July 29, 2015
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
muscles
work
Magnetic Resonance Imaging
control groups

Additional relevant MeSH terms:
Stroke
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on September 01, 2015