Low Intensity Physical Activity Leads to Improvement in Brachial-ankle Pulse Wave Velocity of Hemiplegics (LIPA)

This study has been completed.
Sponsor:
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
  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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01569386

Locations
Japan
Gunma PAZ collge
Takasaki, Gunma, Japan, 3700006
Sponsors and Collaborators
Gunma PAZ College
Kanazawa University
Investigators
Study Chair: Akira Kimura, PhD Gunma PAZ College
  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
Nervous System Diseases
Neurologic Manifestations
Paralysis
Signs and Symptoms

ClinicalTrials.gov processed this record on October 23, 2014