Evaluation of Physical Fitness After Stroke

NCT01107210 | Completed DMC

• 1 other identifier: ML3617
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to examine the evolution and determinants of physical fitness after stroke.

Conditions

Stroke

Keywords

stroke; physical fitness; evolution; determinants

Outcome Measures

Primary Outcomes (1)

• Evolution of physical fitness after stroke, measured by VO2 peak and OUES.

  The criterion standard of cardiorespiratory fitness (VO2max) will be measured during a graded cycle ergometer test. After three minutes of familiarization, the participants will begin to pedal at 10W, with workload increments of 10W/min; they will be instructed to pedal at a comfortable rate between 30 to 60 rpm. Participants will also be monitored with Borg's 16-point Ratings of Perceived Exertion Scale. Maximal effort will be achieved according the ACSM criteria. If no "true" VO2 peak value could be reached, the Oxygen Uptake Efficiency Slope (OUES)will be determined as dependent variable.

  1y follow-up

Secondary Outcomes (1)

• Determinants at functional, activity and participation level of physical fitness after stroke

  1y follow-up

Study Arms (1)

stroke patients

50 patients recruited in the stroke rehabilitation unit in the University Hospital, Leuven, Belgium will be included

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

subjects with a first ever stroke

You may qualify if:

• first-ever stroke as defined by WHO
• aged \< 75 years,
• able to comprehend simple oral instructions.

You may not qualify if:

• other neurological impairments with permanent damage
• stroke-like symptoms due to subdural haematoma, tumour, encephalitis or trauma
• pre-stroke Barthel Index \<50
• unable to perform a maximal exercise test in accordance with absolute contra-indications for exercise testing (ACC/AHA)
• no informed consent.

Sponsors & Collaborators

• KU Leuven: lead
• National Association for Support to Persons with a Disability NVSG: collaborator
• Van Goethem-Brichant foundation: collaborator

Study Sites (1)

University Hospital Leuven, Rehabilitation Centre Pellenberg

Pellenberg, 3212, Belgium

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Ilse Baert, Msc, PT

  KU-Leuven, Faculty of Movement and Rehabilitation Sciences

  PRINCIPAL INVESTIGATOR

• Yves Vanlandewijck, PhD

  KU-Leuven, Faculty of Movement and Rehabilitation Sciences

  STUDY CHAIR

• Daniel Daly, PhD

  KU-Leuven, Faculty of Movement and Rehabilitation Sciences

  STUDY CHAIR

• Hilde Feys, PhD

  KU-Leuven, Faculty of Movement and Rehabilitation Sciences

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 13, 2010
• First Posted: April 20, 2010
• Study Start: May 1, 2006
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: June 23, 2011

Record last verified: 2010-04

Locations

BE (1)