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Body Composition of People After a Stroke

U

University of Rzeszow

Status

Completed

Conditions

Rehabilitation
Stroke
Body Composition

Treatments

Other: Standard rehabilitation after stroke

Study type

Interventional

Funder types

Other

Identifiers

NCT03722602
Stroke-BodyComposition

Details and patient eligibility

About

The study enabled assessment of changes in body mass composition, metabolic syndrome and lipid profile in patients after stroke, following rehabilitation in hospital.

Full description

Stroke is estimated to affect 24-54% of the global population and is one of the leading causes of death. According to World Health Organization over one billion people worldwide are overweight, and approximately 300 million people are obese. The main factors contributing to this situation include insufficient physical activity and unhealthy diet. Among the major consequences of obesity in adults one can distinguish metabolic syndrome and cardiovascular diseases.

Therefore, measurements were performed to identify changes in body mass composition (body fat, visceral fat level, muscle mass, total body water, metabolic syndrome, lipid profile) in subjects after stroke following rehabilitation at hospital.

The study was carried at the Clinical Rehabilitation Ward with Early Neurological Rehabilitation Unit, at the Clinical Hospital in Rzeszów, Poland. The measurements were performed from June 2015 to March 2017. During that time the total of 1,143 patients received treatment and rehabilitation at the clinic. These included 403 patients after stroke. The subjects were examined three times. In accordance with inclusion and exclusion criteria 128 subjects were qualified for the first exam. The second exam took into account 114 subjects and finally 100 patients with stroke participated in the third exam. The analyses took into account the data obtained from the 100 subjects who took part in all the exams. Body mass composition was assessed in all the subjects with Tanita MC 780 MA analyzer, whose operation is based on Bioelectrical impedance analysis (BIA). The subjects' height was measured with the stadiometer PORTSTAND 210. Rehabilitation outcome was assessed with Barthel index, Berg scale, Ashworth scale, Brunnström scale, Rankin scale and symmetry index for lower limb weight distribution (Ws).

In addition, waist and hip circumference were measured and WHR was calculated. The above parameters were assessed three times:

Exam I took place upon admission to hospital Exam II on the day the patient was discharged from hospital Exam III was performed 12 weeks after discharge from hospital during a follow-up visit.

The follow-up visit, 12 weeks after discharge from hospital, was meant to determine whether the effects of rehabilitation persisted for 12 weeks after discharge from hospital.

Other parameters examined included: LDL, HDL, total cholesterol, TG, atherogenic index, CRP, and serum glucose level. Blood for the tests was drawn from basilic vein by medical personnel at the Rehabilitation Clinic. The test was performed twice: upon admission to the Clinic and following 5-week rehabilitation at the hospital.

Enrollment

100 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Stroke experienced.
  • Ability to stand without assistance.
  • Ability to walk without aid.
  • No impairments in higher mental functions
  • Patient's informed, voluntary consent to participate in the study.

Exclusion criteria

  • Lack of patient's consent to participate in the study
  • Lack of ability to stand without assistance.
  • Ischemic lesion located in the cerebellum and brain stem.
  • Metal, electronic implants.
  • Epilepsy.
  • Pregnancy.
  • Menstruation, in females.
  • Limb injuries incurred following stroke onset, prior to the exam.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

100 participants in 1 patient group

Rehabilitation group
Experimental group
Description:
Patients with stroke receiving standard inpatient rehabilitation for five weeks
Treatment:
Other: Standard rehabilitation after stroke

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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