Clinical trial NCT01569386: Low Intensity Physical Activity Leads to Improvement in Brachial-ankle Pulse Wave Velocity of Hemiplegics
Official title: Low Intensity Physical Activity Leads to Improvement in Brachial-ankle Pulse Wave Velocity in the Affected Leg of Hemiplegics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hemiplegia
Motor Activity
Physical Activity
Keywords: pulse wave velocity
low intensity physical activity
hemiplegia
Lead sponsor: Gunma PAZ College
Sponsor class: OTHER
Collaborators: name: Kanazawa University
First posted: 2012-04-03
Enrollment: 54
Sex: MALE
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: brachial- ankle pulse wave velocity(ba-PWV)
timeFrame: Change from Baseline in bar-PWV at 4weeks, 8 weeks and 12weeks
Secondary outcomes:
measure: 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)
timeFrame: Change from Baseline in PIPA, ABI, SBP, and HR, ha-PWV, at 4weeks, 8 weeks and 12weeks
Other outcomes:
Locations:
city: Takasaki
country: Japan
facility: Gunma PAZ collge
state: Gunma
Study officials:
affiliation: Gunma PAZ College
name: Akira Kimura, PhD
role: STUDY_CHAIR
References:
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.