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Clinical Trials/NCT03171012
NCT03171012RecruitingNot Applicable

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 enrollmentStarted: June 19, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
40
Locations
1
Primary Endpoint
Compartmental volumes of the rib cage

Study 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Masking Description

Randomization will be by randomization.com software, where a third person, who will not participate in the other stages of the survey, execute the process and deliver the opaque and numbered envelopes to the researcher responsible for the training, thus ensuring the confidentiality of the allocation. The patient may be allocated to the LL's CRT + PNF group, LL's CRT + Breathing, UL's CRT + PNF or UL's CRT + Breathing.

Eligibility Criteria

Ages
21 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Upper limbs CRT + respiration

Active Comparator

Upper limbs Cardiorespiratory training associated with respiration

Intervention: Upper limbs CRT (Other)

Lower limbs CRT+ PNF

Experimental

Lower Limbs Cardiorespiratory training associated with Proprioceptive Neuromuscular Facilitation

Intervention: Lower limbs CRT (Other)

Lower limbs CRT+ PNF

Experimental

Lower Limbs Cardiorespiratory training associated with Proprioceptive Neuromuscular Facilitation

Intervention: Proprioceptive Neuromuscular Facilitation (Other)

Lower limbs CRT + respiration

Active Comparator

Lower limbs Cardiorespiratory training associated with respiration

Intervention: Lower limbs CRT (Other)

Upper limbs CRT + PNF

Experimental

Upper limbs Cardiorespiratory training associated with Proprioceptive Neuromuscular Facilitation

Intervention: Upper limbs CRT (Other)

Upper limbs CRT + PNF

Experimental

Upper limbs Cardiorespiratory training associated with Proprioceptive Neuromuscular Facilitation

Intervention: Proprioceptive Neuromuscular Facilitation (Other)

Upper limbs CRT + respiration

Active Comparator

Upper limbs Cardiorespiratory training associated with respiration

Intervention: respiration (Other)

Lower limbs CRT + respiration

Active Comparator

Lower limbs Cardiorespiratory training associated with respiration

Intervention: respiration (Other)

Outcomes

Primary Outcomes

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

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.

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))

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Renata Janaína Pereira de Souza

Principal Investigator

Universidade Federal do Rio Grande do Norte

Study Sites (1)

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