Intensity of Task-Oriented Exercises (TOE)

June 23, 2017 updated by: Thin Thin Moe, Mahidol University

Intensity of a Task-Oriented Exercise Program for Optimizing Walking Competency in Stroke Survivors

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Nakhon Pathom
      • Bangkok, Nakhon Pathom, Thailand, 73170
        • Mahidol University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Stroke individuals who able to walk without physical assistance.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 week
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.
1 week
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.
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2016

Primary Completion (Actual)

August 30, 2016

Study Completion (Actual)

August 30, 2016

Study Registration Dates

First Submitted

May 16, 2016

First Submitted That Met QC Criteria

May 19, 2016

First Posted (Estimate)

May 24, 2016

Study Record Updates

Last Update Posted (Actual)

June 26, 2017

Last Update Submitted That Met QC Criteria

June 23, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2-2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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