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Intensity of Task-Oriented Exercises (TOE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02781077
First Posted: May 24, 2016
Last Update Posted: June 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Thin Thin Moe, Mahidol University
  Purpose
In an observational study, the energy consumption of stroke individuals during performing the structured, progressive task-oriented exercise program for walking rehabilitation will be measured in order to confirm the intensity demand in the range of moderate to vigorous.

Condition Intervention
Stroke Procedure: Structured, Progressive, Task-oriented exercise program

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 7 Days
Official Title: Intensity of a Task-Oriented Exercise Program for Optimizing Walking Competency in Stroke Survivors

Resource links provided by NLM:


Further study details as provided by Thin Thin Moe, Mahidol University:

Primary Outcome Measures:
  • Rate of Oxygen Consumption (VO2rate) (ml/kg/min) [ Time Frame: 1 week ]
    The amount of oxygen consumption of participants will be measured by using Oxycon Mobile spirometer (OM) on 3 occasions: during performing step I,II and III of exercise program with 1-2 days apart between each step.


Secondary Outcome Measures:
  • Heart Rate [ Time Frame: 1 week ]
    Heart rate of participants will be measured on 3 occasions: during performing step I,II and III of exercise program with 1-2 days apart between each step

  • Metabolic Equivalents (METs) [VO2max (ml.kg-1.m-1)/VO2rest(ml.kg-1.m-1)] [ Time Frame: 1 week ]
    METs is a way to express the energy cost of activity, calculated by using the formula of VO2/VO2rest on 3 occasions:during performing step I,II and III of exercise program with 1-2 days apart between each step.

  • Borg Rating of Perceived Exertion scale (RPE) [ Time Frame: 1 week ]
    The feeling of how strenuous a given exercise to a patient related to the amount of effort exerted is rated by the categorical-ratio scale of 0 to 10 RPE on 3 occasions: during performing step I,II and III of exercise program with 1-2 days apart between each step.


Enrollment: 10
Actual Study Start Date: July 2016
Study Completion Date: August 30, 2016
Primary Completion Date: August 30, 2016 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Structured, Progressive, Task-oriented exercise program
    The intervention is walking related task-oriented exercise program with three progressive steps at moderate to high intensity. Each step consists of 60 minutes last ten tasks to optimize walking function of stroke individuals.
Detailed Description:
Community reintegration is often significantly affected in the majority of stroke individuals. To fulfill the requirements of a proper home exercise program in walking rehabilitation for stroke victims, investigators structured the task-oriented exercise program with minimal supervision. This exercise program is structured with challenging walking-related activities based on motor learning principle and Gentile's progression of the motor task. The strengthening and balance components, aerobic conditioning and walking adaptability are composed of an exercise program to optimize walking ability. There are sixty minutes last ten exercises in each three progression steps of this exercise program. For the training effect to occur, each step of exercise program is designed by increasing demand of intensity in the range from moderate to vigorous. To confirming progressive energy demand, the purpose of this study is to investigate the intensity demand of three steps task- oriented home exercise program on walking competency in individual post stroke.
  Eligibility

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Stroke individuals who able to walk without physical assistance.
Criteria

Inclusion Criteria:

  1. Either side of both type first stroke with confirmatory diagnosis by CT Scan and MRI.
  2. Age above 20 years old.
  3. Moderate severity of stroke measured by the modified Rankin Scale (mRS- 3)
  4. Able to comprehend the instructions with good cognition measured by Mini-Mental State Examination (MMSE > 23).

Exclusion Criteria:

  1. Diagnosed with other neurological disorder such as Parkinson's disease, peripheral nerve injury.
  2. Serious cardiac conditions (angina and myocardial infarction during the previous month, resting heart rate of more than 120, a systolic blood pressure of more than 180 mm Hg, and a diastolic blood pressure of more than 100 mm Hg)
  3. Fugl Meyer Assessment score (lower extremity) less than ≤ 21
  4. Significant hip, knee and ankle contracture that would limit ambulation (Fugl Meyer (ROM) ≤1 in each joint).
  5. Orthopedic and rheumatological disorder with weight bearing pain (Fugl Meyer (pain) ≤ 1 in hip, knee and ankle joint movement).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02781077


Locations
Thailand
Mahidol University
Bangkok, Nakhon Pathom, Thailand, 73170
Sponsors and Collaborators
Mahidol University
Investigators
Principal Investigator: Thin Thin Moe, M.Med.Tech Mahidol University
Study Chair: Chutima Jalayondeja, Dr.P.H. MSc Mahidol University
Study Director: Sopa Pichaiyongwongdee, M.Sc. B.Sc Mahidol University
Study Director: Vimonwan Hiengkaew, PhD. MSc Mahidol University
Study Director: Jarugool Tretriluxana, PhD. MSc Mahidol University
  More Information

Responsible Party: Thin Thin Moe, Ph D candidate, Mahidol University
ClinicalTrials.gov Identifier: NCT02781077     History of Changes
Other Study ID Numbers: 2-2016
First Submitted: May 16, 2016
First Posted: May 24, 2016
Last Update Posted: June 26, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Thin Thin Moe, Mahidol University:
Stroke
walking competency
Task-oriented exercise program
Exercise intensity

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