Intensity of Task-Oriented Exercises

Completed

• Conditions: Stroke

• Registration Number: NCT02781077
• Lead Sponsor: Mahidol University

Brief Summary

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-05-16
• Study First Submitted QC: 2016-05-19
• Study First Posted: 2016-05-24
• Study Start: 2016-07
• Primary Completion: 2016-08-30
• Study Completion: 2016-08-30
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-23
• Last Update Posted: 2017-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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).

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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).

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of Oxygen Consumption (VO2rate) (ml/kg/min)	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

Name	Time	Method
Heart Rate	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)]	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)	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.

Trial Locations

Locations (1)

Mahidol University; 🇹🇭 Bangkok, Nakhon Pathom, Thailand