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Completed

NCT Number: NCT02781077

Intensity of Task-Oriented Exercises

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.

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Key information

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Mahidol University

Bangkok, Changwat Nakhon Pathom, 73170, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Diagnosed with other neurological disorder such as Parkinson's disease, peripheral nerve injury.
  • 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)
  • Fugl Meyer Assessment score (lower extremity) less than ≤ 21
  • Significant hip, knee and ankle contracture that would limit ambulation (Fugl Meyer (ROM) ≤1 in each joint).
  • Orthopedic and rheumatological disorder with weight bearing pain (Fugl Meyer (pain) ≤ 1 in hip, knee and ankle joint movement).

Treatment and study plan

Structured, Progressive, Task-oriented exercise program

Procedure

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.

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

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

Acronym: TOE

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
May 24, 2016
Registry last updated
Jun 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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