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

NCT01569386 | Completed Phase 2 DMC

• 1 other identifier: UMIN000007598
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemiplegia; Motor Activity; Physical Activity

Keywords

pulse wave velocity; low intensity physical activity; hemiplegia

Outcome Measures

Primary Outcomes (1)

• 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.

  Change from Baseline in bar-PWV at 4weeks, 8 weeks and 12weeks

Secondary Outcomes (1)

• 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)

  Change from Baseline in PIPA, ABI, SBP, and HR, ha-PWV, at 4weeks, 8 weeks and 12weeks

Study Arms (2)

low intensity physical activity

EXPERIMENTAL

Daily low intensity physical activity by the half squat

Behavioral: Daily low intensity physical activity by the half squat

stretch exercise and usual activity

ACTIVE COMPARATOR

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

Behavioral: stretch exercise and usual activity

Interventions

Daily low intensity physical activity by the half squat BEHAVIORAL

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.

Also known as: low intensity physical activity

low intensity physical activity

stretch exercise and usual activity BEHAVIORAL

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.

Also known as: whole body stretch exercise and usual activity

stretch exercise and usual activity

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gunma PAZ College: lead
• Kanazawa University: collaborator

Study Sites (1)

Gunma PAZ collge

Takasaki, Gunma, 3700006, Japan

Location

Related Publications (1)

• 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.

  PMID: 19533871 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Hemiplegia; Motor Activity

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Akira Kimura, PhD

  Gunma PAZ College

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 29, 2012
• First Posted: April 3, 2012
• Study Start: June 1, 2004
• Primary Completion: February 1, 2007
• Study Completion: February 1, 2012
• Last Updated: April 3, 2012

Record last verified: 2012-04

Locations

JP (1)