Intensity of Task-Oriented Exercises

Stroke Clinical Trial

— TOE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02781077
• Other study ID #: 2-2016
• Status: Completed
• Phase: N/A
• First received: May 16, 2016
• Last updated: June 23, 2017
• Start date: July 2016
• Est. completion date: August 30, 2016

Study information

• Verified date: June 2017
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: August 30, 2016
• Est. primary completion date: August 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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).

Related Conditions & MeSH terms

• Stroke

Intervention

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.

Locations

Country	Name	City	State
Thailand	Mahidol University	Bangkok	Nakhon Pathom

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Oxygen Consumption (VO2rate) (ml/kg/min)	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	Heart Rate	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
Secondary	Metabolic Equivalents (METs) [VO2max (ml.kg-1.m-1)/VO2rest(ml.kg-1.m-1)]	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
Secondary	Borg Rating of Perceived Exertion scale (RPE)	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