Clinical trial NCT02781077: Intensity of Task-Oriented Exercises
Official title: Intensity of a Task-Oriented Exercise Program for Optimizing Walking Competency in Stroke Survivors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Keywords: Stroke
walking competency
Task-oriented exercise program
Exercise intensity
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2016-05-24
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stroke individuals who able to walk without physical assistance.

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.

Eligibility 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).

Primary outcomes:
measure: Rate of Oxygen Consumption (VO2rate) (ml/kg/min)
timeFrame: 1 week
Secondary outcomes:
measure: Heart Rate
timeFrame: 1 week
measure: Metabolic Equivalents (METs) [VO2max (ml.kg-1.m-1)/VO2rest(ml.kg-1.m-1)]
timeFrame: 1 week
measure: Borg Rating of Perceived Exertion scale (RPE)
timeFrame: 1 week
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Mahidol University
state: Nakhon Pathom
Study officials:
affiliation: Mahidol University
name: Thin Thin Moe, M.Med.Tech
role: PRINCIPAL_INVESTIGATOR
affiliation: Mahidol University
name: Chutima Jalayondeja, Dr.P.H. MSc
role: STUDY_CHAIR
affiliation: Mahidol University
name: Sopa Pichaiyongwongdee, M.Sc. B.Sc
role: STUDY_DIRECTOR
affiliation: Mahidol University
name: Vimonwan Hiengkaew, PhD. MSc
role: STUDY_DIRECTOR
affiliation: Mahidol University
name: Jarugool Tretriluxana, PhD. MSc
role: STUDY_DIRECTOR
References: