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

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ClinicalTrials.gov Identifier: NCT01569386
Recruitment Status : Completed
First Posted : April 3, 2012
Last Update Posted : April 3, 2012
Sponsor:
Collaborator:
Kanazawa University
Information provided by (Responsible Party):
Akira Kimura,PhD, Gunma PAZ College

Tracking Information
First Submitted Date  ICMJE March 29, 2012
First Posted Date  ICMJE April 3, 2012
Last Update Posted Date April 3, 2012
Study Start Date  ICMJE June 2004
Actual Primary Completion Date February 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 2, 2012)
brachial- ankle pulse wave velocity(ba-PWV) [ Time Frame: Change from Baseline in bar-PWV at 4weeks, 8 weeks and 12weeks ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 2, 2012)
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 ]
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Low Intensity Physical Activity Leads to Improvement in Brachial-ankle Pulse Wave Velocity of Hemiplegics
Official Title  ICMJE Low Intensity Physical Activity Leads to Improvement in Brachial-ankle Pulse Wave Velocity in the Affected Leg of Hemiplegics
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Hemiplegia
  • Motor Activity
  • Physical Activity
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: low intensity physical activity
    Daily low intensity physical activity by the half squat
    Intervention: Behavioral: Daily low intensity physical activity by the half squat
  • Active Comparator: stretch exercise and usual activity
    They do whole body stretch exercise for 20 minute in a day
    Intervention: Behavioral: stretch exercise and usual activity
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 2, 2012)
54
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2012
Actual Primary Completion Date February 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 65 Years to 90 Years   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01569386
Other Study ID Numbers  ICMJE UMIN000007598
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Akira Kimura,PhD, Gunma PAZ College
Study Sponsor  ICMJE Gunma PAZ College
Collaborators  ICMJE Kanazawa University
Investigators  ICMJE
Study Chair: Akira Kimura, PhD Gunma PAZ College
PRS Account Gunma PAZ College
Verification Date April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP