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

Primary Purpose

Hemiplegia, Motor Activity, Physical Activity

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Daily low intensity physical activity by the half squat
stretch exercise and usual activity
Sponsored by
Gunma PAZ College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemiplegia focused on measuring pulse wave velocity, low intensity physical activity, hemiplegia

Eligibility Criteria

65 Years - 90 Years (Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Gunma PAZ collge

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

low intensity physical activity

stretch exercise and usual activity

Arm Description

Daily low intensity physical activity by the half squat

They do whole body stretch exercise for 20 minute in a day

Outcomes

Primary Outcome Measures

brachial- ankle pulse wave velocity(ba-PWV)
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)
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.

Full Information

First Posted
March 29, 2012
Last Updated
April 2, 2012
Sponsor
Gunma PAZ College
Collaborators
Kanazawa University
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1. Study Identification

Unique Protocol Identification Number
NCT01569386
Brief Title
Low Intensity Physical Activity Leads to Improvement in Brachial-ankle Pulse Wave Velocity of Hemiplegics
Acronym
LIPA
Official Title
Low Intensity Physical Activity Leads to Improvement in Brachial-ankle Pulse Wave Velocity in the Affected Leg of Hemiplegics
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gunma PAZ College
Collaborators
Kanazawa University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiplegia, Motor Activity, Physical Activity
Keywords
pulse wave velocity, low intensity physical activity, hemiplegia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
low intensity physical activity
Arm Type
Experimental
Arm Description
Daily low intensity physical activity by the half squat
Arm Title
stretch exercise and usual activity
Arm Type
Active Comparator
Arm Description
They do whole body stretch exercise for 20 minute in a day
Intervention Type
Behavioral
Intervention Name(s)
Daily low intensity physical activity by the half squat
Other Intervention Name(s)
low intensity physical activity
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
stretch exercise and usual activity
Other Intervention Name(s)
whole body stretch exercise and usual activity
Intervention Description
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.
Primary Outcome Measure Information:
Title
brachial- ankle pulse wave velocity(ba-PWV)
Description
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.
Time Frame
Change from Baseline in bar-PWV at 4weeks, 8 weeks and 12weeks
Secondary Outcome Measure Information:
Title
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)
Description
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.
Time Frame
Change from Baseline in PIPA, ABI, SBP, and HR, ha-PWV, at 4weeks, 8 weeks and 12weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Akira Kimura, PhD
Organizational Affiliation
Gunma PAZ College
Official's Role
Study Chair
Facility Information:
Facility Name
Gunma PAZ collge
City
Takasaki
State/Province
Gunma
ZIP/Postal Code
3700006
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
19533871
Citation
Kimura A, Miyagi S. A pilot study of advice on physical activity in senior disabled individuals in rural Japan. Asia Pac J Public Health. 2008 Oct;20 Suppl:128-33.
Results Reference
background
Links:
URL
http://kimuakilabo.main.jp/
Description
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Low Intensity Physical Activity Leads to Improvement in Brachial-ankle Pulse Wave Velocity of Hemiplegics

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