Low Intensity Physical Activity Leads to Improvement in Brachial-ankle Pulse Wave Velocity of Hemiplegics (LIPA)
This study has been completed.
Sponsor:
Gunma PAZ College
Collaborator:
Kanazawa University
Information provided by (Responsible Party):
Akira Kimura,PhD, Gunma PAZ College
ClinicalTrials.gov Identifier:
NCT01569386
First received: March 29, 2012
Last updated: April 2, 2012
Last verified: April 2012
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Purpose
Low intensity physical activity by half squat of the elderly people with hemiplegia significantly slow down the pulse wave velocity of the arteries of the lower limbs of the paralyzed side within 8 weeks.
| Condition | Intervention | Phase |
|---|---|---|
|
Hemiplegia Motor Activity Physical Activity |
Behavioral: Daily low intensity physical activity by the half squat Behavioral: stretch exercise and usual activity |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Low Intensity Physical Activity Leads to Improvement in Brachial-ankle Pulse Wave Velocity in the Affected Leg of Hemiplegics |
Resource links provided by NLM:
Further study details as provided by Gunma PAZ College:
Primary Outcome Measures:
- brachial- ankle pulse wave velocity(ba-PWV) [ Time Frame: Change from Baseline in bar-PWV at 4weeks, 8 weeks and 12weeks ] [ Designated as safety issue: No ]baPWV were measured using the recently developed device, form ABI/PWV (BP-203RPE; Nihon Colin). This device has four cuffs that can be used to simultaneously measure blood pressure in both arms and both legs, and automatically calculate the ABI. It also records pulse waves with the sensors in the cuffs, computes the difference between transmission time in the arm and transmission time in the ankle, calculates the transmission distance from the right arm to each ankle according to body height, and thus computes the baPWV values from the transmission time and transmission distance.
Secondary Outcome Measures:
- physical activity levels based on posture and intensity(PIPA), resting heart rate(HR), systolic blood pressure(SBP), ankle-brachial pressure indexABI), heart-aortic pulse wave velocity(ha-PWV) [ Time Frame: Change from Baseline in PIPA, ABI, SBP, and HR, ha-PWV, at 4weeks, 8 weeks and 12weeks ] [ Designated as safety issue: No ]ABI,HR,SBP,ha-PWV were measured using the recently developed device, form ABI/PWV (BP-203RPE; Nihon Colin). This device has four cuffs that can be used to simultaneously measure blood pressure in both arms and both legs, and automatically calculate the ABI. It also records pulse waves with the sensors in the cuffs, computes the difference between transmission time in the arm and transmission time in the ankle, calculates the transmission distance from the right arm to each ankle according to body height, and thus computes the haPWV values from the transmission time and transmission distance.
| Enrollment: | 54 |
| Study Start Date: | June 2004 |
| Study Completion Date: | February 2012 |
| Primary Completion Date: | February 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: low intensity physical activity
Daily low intensity physical activity by the half squat
|
Behavioral: Daily low intensity physical activity by the half squat
They take a meal three times daily. They are a time to do the manual work every day. They watch the TV for two hours every day. And they do a walk of 30 minutes every day. They do a specific exercise. They were trained to conduct 40kcal period(about 20 min.) for adding to the amount of energy consumption of low-intensity physical activity at baseline.Specific exercise that was done the half squat(max knee flexion 70 degree). This squat is carried out in two seconds round trip. This squat is carried out in two seconds round trip. They grab the edge of the table. They put half the weight of the lower limbs paralyzed side. This observer once a week, to record their behavior over 24 hours. Intervention period is up to a maximum of 12 weeks.
Other Name: low intensity physical activity
|
|
Active Comparator: stretch exercise and usual activity
They do whole body stretch exercise for 20 minute in a day
|
Behavioral: stretch exercise and usual activity
They take a meal three times daily.They are a time to do the manual work every day.They watch the TV for two hours every day.And they do a walk of 30 minutes every day.They do whole body stretch exercise for 20 minute in a day. An observer once a week, to record their behavior over 24 hours.Their behavior was used to calculate the amount of energy consumption.They are informed of the kcal a day from the viewer.
Other Name: whole body stretch exercise and usual activity
|
Detailed Description:
Measurement of aortic pulse wave velocity (PWV) is a noninvasive method for assessing arterial stiffening in atherosclerosis. In hemiplegics, disuse of the affected limb is associated with the muscle wasting leading to development of local atherosclerosis. The brachial-ankle aortic PWV (baPWV) is an indicator of early stage disuse syndrome, and is measured with a device that is particularly useful in elderly hemiplegics.
The LIPA regime was designed to result in an increase of 3.3% (about 40 kcal/day) of daily energy consumption compared to their individual baseline values. This included aerobic exercises and half squats (70° knee flexion) for altogether about 20 minutes, once daily. In addition, the subjects performed passive ankle dorsiflexion-plantar flexion, 30 times/minute for 10 min, once daily. The LIPA was aimed at affecting the passive range of motion in ankle, knee, and hip, and weight bearing on the affected leg in standing position.
Eligibility| Ages Eligible for Study: | 65 Years to 90 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- age above 65 years
- male
- hemiplegic
- onset of stroke within 5 years
- some of them required walking aid indoors
- all of them required a walking aid outdoors
Exclusion Criteria:
- severe functional limitations that precluded any increase in PA
- presence of associated cardiovascular conditions such as uncontrolled hypertension or angina
- presence of undiagnosed or untreated health conditions that manifested as abnormal findings in laboratory test and contraindicated exercise tests
Contacts and Locations More Information
Additional Information:
Publications:
| Responsible Party: | Akira Kimura,PhD, Professor, Gunma PAZ College |
| ClinicalTrials.gov Identifier: | NCT01569386 History of Changes |
| Other Study ID Numbers: | UMIN000007598 |
| Study First Received: | March 29, 2012 |
| Last Updated: | April 2, 2012 |
| Health Authority: | Japan: Ministry of Education, Culture, Sports, Science and Technology |
Keywords provided by Gunma PAZ College:
|
pulse wave velocity low intensity physical activity hemiplegia |
Additional relevant MeSH terms:
|
Hemiplegia Paralysis Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013