Clinical trial NCT03722602: Body Composition of People After a Stroke
Official title: Effect of Rehabilitation on the Body Composition in Patients With Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rehabilitation
Stroke
Body Composition
Keywords: stroke
BMI
body composition
functional scales
Lead sponsor: University of Rzeszow
Sponsor class: OTHER
First posted: 2018-10-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change Body composition assessment (fat mass, visceral fat level , muscle tissue, fat free mass , water content in the body) subjected to bioelectrical impedancy analysis - Tanita 780.
timeFrame: at baseline, immediately after treatment completion, and 12 weeks after treatment completion
Secondary outcomes:
measure: Assessment of functional status was assessed using the Barthel Index. The subjects could score the maximum of 100 points.
timeFrame: at baseline, immediately after treatment completion, and 12 weeks after treatment completion
measure: Balance was assessed using Berg Balance Scale (BBS)
timeFrame: at baseline, immediately after treatment completion, and 12 weeks after treatment completion
measure: Assessment of muscle tone (spasticity) was examined with modified Ashworth scale.
timeFrame: at baseline, immediately after treatment completion, and 12 weeks after treatment completion
measure: Assessment of paretic limb function was assessed using the Brunnström scale.
timeFrame: at baseline, immediately after treatment completion, and 12 weeks after treatment completion
measure: Assessment of symmetry index for lower limb weight distribution
timeFrame: at baseline, immediately after treatment completion, and 12 weeks after treatment completion
measure: Assessment of disability level, using the modified Rankin scale (MRS)
timeFrame: at baseline, immediately after treatment completion, and 12 weeks after treatment completion
measure: Changes in blood parameter: HDL
timeFrame: at 5 weeks between baseline, after the end of protocol treatment,
measure: Changes in blood parameter: LDL
timeFrame: at 5 weeks between baseline, after the end of protocol treatment
measure: Changes in blood parameter: total cholesterol
timeFrame: at 5 weeks between baseline, after the end of protocol treatment
measure: Assessment of WHR
timeFrame: at 5 weeks between baseline, after the end of protocol treatment, and 12 weeks after treatment completion
measure: Assessment of metabolic syndrome
timeFrame: at 5 weeks between baseline, after the end of protocol treatment
measure: Changes in blood parameter: TG
timeFrame: at 5 weeks between baseline, after the end of protocol treatment,
measure: Changes in blood parameter: atherogenic index
timeFrame: at 5 weeks between baseline, after the end of protocol treatment,
measure: Changes in blood parameter: CRP
timeFrame: at 5 weeks between baseline, after the end of protocol treatment,
measure: Changes in blood parameter: serum glucose
timeFrame: at 5 weeks between baseline, after the end of protocol treatment,
Other outcomes:
Locations:
city: Rzeszów
country: Poland
facility: University of Rzeszów
Study officials:
affiliation: University of Rzeszow
name: Justyna Leszczak, PhD
role: PRINCIPAL_INVESTIGATOR
References: