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

NCT00721357 | Completed Results

• 1 other identifier: B6341-W
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke

Keywords

muscles; work; Magnetic Resonance Imaging; control groups

Outcome Measures

Primary Outcomes (1)

• Oxygen Consumption During Walking

  Amount of oxygen consumed during walking at self-selected speed normalized to speed

  within one week of enrollment

Secondary Outcomes (2)

• Muscle Mechanical Energy Expenditure

  one time measure within one week of enrollment

• Magnetic Resonance Spectroscopy of Muscle Metabolic Properties

  within one week of enrollment

Study Arms (2)

Stroke

Stroke subjects

Behavioral: Treadmill walking; Other: Magnetic resonance spectroscopy

Control

neurologically healthy subjects

Behavioral: Treadmill walking; Other: Magnetic resonance spectroscopy

Interventions

Treadmill walking BEHAVIORAL

Subjects will perform treadmill walking at a self-selected velocity

Control; Stroke

Magnetic resonance spectroscopy OTHER

Muscle oxidative capacity will be assessed via Magnetic resonance spectroscopy (31P-MRS)

Control; Stroke

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

community sample

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Medical University of South Carolina: collaborator

Study Sites (1)

Ralph H. Johnson VA Medical Center, Charleston, SC

Charleston, South Carolina, 29401-5799, United States

Location

Biospecimen

Retention: NONE RETAINED

None retained

MeSH Terms

Conditions

Stroke

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Results Point of Contact

• Title: Chris Gregory
• Organization: Ralph H Johnson VAMC

Christopher.Gregory@va.gov

(843)792-1078

Study Officials

• Chris M. Gregory, PhD

  Ralph H. Johnson VA Medical Center, Charleston, SC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2008
• First Posted: July 24, 2008
• Study Start: August 1, 2008
• Primary Completion: July 1, 2012
• Study Completion: September 1, 2013
• Last Updated: March 18, 2019
• Results First Posted: July 30, 2015

Record last verified: 2018-12

Locations

US (1)