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Clinical Trials/NCT03171012
NCT03171012
Recruiting
N/A

Proprioceptive Neuromuscular Facilitation Repercussions Associated With Cardiorespiratory Training in Postal Individuals Stroke to the Functions Motor, Respiratory and Quality of Life: Randomized Controlled Trial

Universidade Federal do Rio Grande do Norte1 site in 1 country40 target enrollmentJune 19, 2017

Overview

Phase
N/A
Intervention
Not specified
Conditions
Stroke
Sponsor
Universidade Federal do Rio Grande do Norte
Enrollment
40
Locations
1
Primary Endpoint
Oxygen uptake
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

Post-stroke hemiparesis causes sequelae in the limbs and also in the trunk and abdomen structures. The level of physical activity decreases and cardiorespiratory training(CRT) is indicated to this population to improve the functions of several systems (respiratory, cardiovascular, muscular). The application of Proprioceptive Neuromuscular Facility(PNF) would imply in the awareness and greater harmony of the functions performed by the trunk of this individual. The objective of this study is to evaluate the effects of respiratory and trunk characteristics of the PNF associated with Cardiorespiratory training in quality of life, gait, distance traveled, peak oxygen consumption, respiratory muscle strength, thoracic cavity volumes, mobility and diaphragmatic thickness of individuals with post stroke.

Detailed Description

Clinical, randomized, blind and allocation. Forty individuals post-stroke will be randomized into four groups: Experimental Lower Limbs(submitted to LL's CRT associated with PNF); Group control Lower Limbs (submitted LL's CRT associated with respiration). Experimental Upper Limbs (submitted to UP's CRT associated with PNF) and Group control Upper Limbs (submitted to UP's CRT associated with respiration). Individuals will be assessed before and immediately after 20 program sessions and one month after the end of treatment. Outcome measures shall be measured by: Stroke Specific Quality of Life Scale; Inertial gear sensor; Maximum volume of oxygen; Spirometry and manovacuometry; Ultrasound of mobility and thickness diaphragmatic; compartmental volumes of the rib cage with opto plethysmography electronics. For the four groups, the treatment program will have the total duration of one hour including: ten minutes of stretching (five minutes before and five minutes after the therapeutic intervention), ten minutes of rest and 40 minutes of aerobic treatment associated to PNF or to respiration, being performed in 20 Sessions three times a week. The order of application of the techniques will be random, being held until the end of the intervention period. For therapy with the CRT used the cycle ergometer for lower or upper limbs, Based on the criteria of the American College of Sports Medicine and monitoring constant blood pressure, oxygen saturation and perceived exertion. The PNF patterns will be performed in seated, dorsal, ventral and side. The breathing exercises will be performed at the same time and in the positions of the PNF. To analyze the data and to achieve the objectives appropriate statistical tests shall be used, according to the normality of and characteristics of the variables.

Registry
clinicaltrials.gov
Start Date
June 19, 2017
End Date
June 2026
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Renata Janaína Pereira de Souza

Principal Investigator

Universidade Federal do Rio Grande do Norte

Eligibility Criteria

Inclusion Criteria

  • Have clinical diagnosis of ischemic or hemorrhagic stroke,
  • primary for more than six months resulting in hemiparesis;
  • Have mental competence assessed through the Mini-Exam of the Mental State-MMSE;
  • Be able to walk 10 meters independently, with or without assistive device;
  • Absence of other neurological or orthopedic deficiencies unrelated to stroke;
  • Without report of associated pulmonary pathology and not be smoker or ex-smoker.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Oxygen uptake

Time Frame: Three months total: After 20 sessions of intervention(2 months) and after 1 months without treatment (follow-up)

maximum oxygen volume consumed during the 6-minute walk test

Balance

Time Frame: Three months total: After 20 sessions of intervention(2 months) and after 1 months without treatment (follow-up)

The scale assesses the balance based on 14 common items of day-to-day.

Quality of life

Time Frame: Three months total: After 20 sessions of intervention(2 months) and after 1 months without treatment (follow-up)

12 domains: Energy (3 items); Family Relationships (3 items); Language (5 items); Mobility (6 items); Mood (5 items); Personality (3 items); Self-Care (5 items), Superior Member Function (5 items), Social Relations (5 items), Memory / Concentration (3 items), Vision (3 items) and Work / Productivity (3 items).

Gait

Time Frame: Three months total: After 20 sessions of intervention(2 months) and after 1 months without treatment (follow-up)

Wireless system consisting of an inertial sensor, consisting of a 3-axis accelerometer, a magnetic sensor and a 3-axis gyroscope, which positioned in L5 allows a functional gait analysis. The system calculates from the data obtained all the temporal and spatial gait parameters required to perform a diagnosis or to define a training strategy. The distance traveled, time of support and balance, step size.

Compartmental volumes of the rib cage

Time Frame: Three months total: After 20 sessions of intervention(2 months) and after 1 months without treatment (follow-up)

Analysis of the kinematics of the thoracic wall through the optical-electronic plethysmograph

Secondary Outcomes

  • Respiratory function(Three months total:After 20 sessions of intervention(2 months) and after 1 months without treatment (follow-up))
  • Inspiratory muscle strength(Three months total: After 20 sessions of intervention(2 months) and after 1 months without treatment (follow-up))
  • Expiratory muscle strength(Three months total: After 20 sessions of intervention(2 months) and after 1 months without treatment (follow-up))
  • Diaphragmatic thickness(Three months total: After 20 sessions of intervention(2 months) and after 1 months without treatment (follow-up))
  • Mobility diaphragmatic(Three months total:After 20 sessions of intervention(2 months) and after 1 months without treatment (follow-up))
  • Oxygen Uptake Efficiency Slope(Three months total:After 20 sessions of intervention(2 months) and after 1 months without treatment (follow-up))

Study Sites (1)

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