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

NCT ID: NCT01569386

Last Updated: 2012-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-06-30
• Study Completion Date: 2012-02-29

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.

Conditions

Hemiplegia; Motor Activity; Physical Activity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

low intensity physical activity

Daily low intensity physical activity by the half squat

Group Type: EXPERIMENTAL

Daily low intensity physical activity by the half squat

Intervention Type: 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.

stretch exercise and usual activity

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

Group Type: ACTIVE_COMPARATOR

stretch exercise and usual activity

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

low intensity physical activity; whole body stretch exercise and usual activity

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

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Kanazawa University

OTHER

Sponsor Role: collaborator

Gunma PAZ College

OTHER

Sponsor Role: lead

Responsible Party

Akira Kimura,PhD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Akira Kimura, PhD

Role: STUDY_CHAIR

Gunma PAZ College

Locations

Gunma PAZ collge

Takasaki, Gunma, Japan

Countries

Japan

References

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.

Reference Type: BACKGROUND

PMID: 19533871 (View on PubMed)

Related Links

http://kimuakilabo.main.jp/

Related Info

Other Identifiers

UMIN000007598

Identifier Type: -

Identifier Source: org_study_id