Body Composition of People After a Stroke

NCT ID: NCT03722602

Last Updated: 2018-10-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2017-03-31

Brief Summary

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

Detailed 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.

Conditions

Rehabilitation; Stroke; Body Composition

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rehabilitation group

Patients with stroke receiving standard inpatient rehabilitation for five weeks

Group Type: EXPERIMENTAL

Standard rehabilitation after stroke

Intervention Type: OTHER

The program of the rehabilitation was designed specifically for each patient. It was prepared to match the patient's functional status and the defined goals. The subjects participated in exercise five days per week, for five weeks. During their stay at the Clinic, the patients took part in morning exercise and received individual practice, based on neuro-developmental treatment (Bobath concept), and proprioceptive neuromuscular facilitation (PNF) method, addressing the impaired motor abilities; if it was needed they also performed exercise based on equipment using biological feedback: Balance Trainer (static and dynamic parapodium) and Pablo system designed for upper limb training.

Interventions

Standard rehabilitation after stroke

The program of the rehabilitation was designed specifically for each patient. It was prepared to match the patient's functional status and the defined goals. The subjects participated in exercise five days per week, for five weeks. During their stay at the Clinic, the patients took part in morning exercise and received individual practice, based on neuro-developmental treatment (Bobath concept), and proprioceptive neuromuscular facilitation (PNF) method, addressing the impaired motor abilities; if it was needed they also performed exercise based on equipment using biological feedback: Balance Trainer (static and dynamic parapodium) and Pablo system designed for upper limb training.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Rzeszow

OTHER

Sponsor Role: lead

Responsible Party

Justyna Leszczak

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Justyna Leszczak, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Rzeszow

Locations

University of Rzeszów

Rzeszów, , Poland

Countries

Poland

Other Identifiers

Stroke-BodyComposition

Identifier Type: -

Identifier Source: org_study_id