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Completed

NCT Number: NCT01569386

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

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.

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Key information

Conditions

Hemiplegia Behavior Motor Activity Nervous System Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Physical Activity Signs and Symptoms

Age range

65 year–90 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Gunma PAZ collge

Takasaki, Gunma, 3700006, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: 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.

Other names: whole body stretch exercise and usual activity

Primary outcomes

  1. 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.

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)

    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.

Sponsors and collaborators

Lead sponsor

Gunma PAZ College

Other

Collaborators

  • Kanazawa University

Registry information

Official study title

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

Acronym: LIPA

Important dates

Study start
2004
Primary completion
2007
Study completion
2012
First posted
Apr 3, 2012
Registry last updated
Apr 3, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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