Addition of Proprioceptive Neuromuscular Facilitation to Cardio Respiratory Training Post Stroke

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

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Quality of Life; Chest Wall Disorder
• Intervention / Treatment: Other: Lower limbs CRT; Other: Proprioceptive Neuromuscular Facilitation; Other: respiration; Other: Upper limbs CRT

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: RENATA SOUZA, MASTER; Phone Number: 55 81 999069957; Email: FTRJPS@GMAIL.COM

Study Locations

• Brazil
  • Pernambuco
    • Recife, Pernambuco, Brazil, 50740 - 560
      • Recruiting
      • Universidade Federal de Pernambuco
      • Contact: Renata Souza; Phone Number: +55 81 999069957; Email: ftrjps@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lower limbs CRT+ PNF; Lower Limbs Cardiorespiratory training associated with Proprioceptive Neuromuscular Facilitation	Other: Lower limbs CRT; cycle ergometer for lower limbs; Other: Proprioceptive Neuromuscular Facilitation; Proprioceptive Neuromuscular Facilitation patterns will be performed in seated, dorsal, ventral and side.
Active Comparator: Lower limbs CRT + respiration; Lower limbs Cardiorespiratory training associated with respiration	Other: Lower limbs CRT; cycle ergometer for lower limbs; Other: respiration; respiration
Experimental: Upper limbs CRT + PNF; Upper limbs Cardiorespiratory training associated with Proprioceptive Neuromuscular Facilitation	Other: Proprioceptive Neuromuscular Facilitation; Proprioceptive Neuromuscular Facilitation patterns will be performed in seated, dorsal, ventral and side.; Other: Upper limbs CRT; cycle ergometer for upper limbs
Active Comparator: Upper limbs CRT + respiration; Upper limbs Cardiorespiratory training associated with respiration	Other: respiration; respiration; Other: Upper limbs CRT; cycle ergometer for upper limbs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxygen uptake	maximum oxygen volume consumed during the 6-minute walk test	Three months total: After 20 sessions of intervention(2 months) and after 1 months without treatment (follow-up)
Balance	The scale assesses the balance based on 14 common items of day-to-day.	Three months total: After 20 sessions of intervention(2 months) and after 1 months without treatment (follow-up)
Quality of life	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).	Three months total: After 20 sessions of intervention(2 months) and after 1 months without treatment (follow-up)
Gait	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.	Three months total: After 20 sessions of intervention(2 months) and after 1 months without treatment (follow-up)
Compartmental volumes of the rib cage	Analysis of the kinematics of the thoracic wall through the optical-electronic plethysmograph	Three months total: After 20 sessions of intervention(2 months) and after 1 months without treatment (follow-up)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory function	Spirometry: Will be measured slow vital capacity (Measured in liters), Inspiratory capacity (Measured in liters), forced expiratory volume in the first second (Measured in liters), Forced vital capacity (Measured in liters), forced expiratory volume ratio in the first second by forced vital capacity, peak expiratory flow (Measured in liters per minute).	Three months total:After 20 sessions of intervention(2 months) and after 1 months without treatment (follow-up)
Inspiratory muscle strength	Manovacuometry: Maximal Inspiratory pressure (MIP), Measured in centimeters of water	Three months total: After 20 sessions of intervention(2 months) and after 1 months without treatment (follow-up)
Expiratory muscle strength	Manovacuometry: maximal expiratory pressure (MEP), Measured in centimeters of water	Three months total: After 20 sessions of intervention(2 months) and after 1 months without treatment (follow-up)
Diaphragmatic thickness	Measurement of the diaphragmatic thickness from the middle of the pleural line to the middle of the peritoneal line.	Three months total: After 20 sessions of intervention(2 months) and after 1 months without treatment (follow-up)
Mobility diaphragmatic	Using convex transducer (3.5MHz) positioned in the right axillary line below the costal margin, the examiner will maintain a firm hand towards the cranial direction. The cranio-caudal excursions of the diaphragm during quiet and forced breathing will record sinusoidal curves, which will represent the diaphragmatic mobility when the trajectory between the baseline at the beginning of the inspiration and the line obtained at the peak of the inspiration is verified.	Three months total:After 20 sessions of intervention(2 months) and after 1 months without treatment (follow-up)
Oxygen Uptake Efficiency Slope	The OUES reflects the relationship between oxygen uptake(˙VO 2 in ml/min) and total ventilation (VE in L/min) and is best described by a single exponential function in almost all subjects. This index was determined by the following equation: VO2 = a log10VE + b When VO 2 in ml/min is plotted on the y axis and VE in L/min is plotted on the semilog transformed x axis, the slope of this linear relationship, "a", represents the OUES.	Three months total:After 20 sessions of intervention(2 months) and after 1 months without treatment (follow-up)

Collaborators and Investigators

• Sponsor: Universidade Federal do Rio Grande do Norte
• Investigators: Principal Investigator: RENATA SOUZA, MASTER, Universidade Federal do Rio Grande do Norte

Publications and helpful links

General Publications

• de Souza RJP, Brandao DC, Martins JV, Fernandes J, Dornelas de Andrade A. Addition of proprioceptive neuromuscular facilitation to cardiorespiratory training in patients poststroke: study protocol for a randomized controlled trial. Trials. 2020 Feb 14;21(1):184. doi: 10.1186/s13063-019-3923-1.

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2017
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): June 1, 2026

Study Registration Dates

• First Submitted: May 23, 2017
• First Submitted That Met QC Criteria: May 25, 2017
• First Posted (Actual): May 31, 2017

Study Record Updates

• Last Update Posted (Estimate): May 11, 2023
• Last Update Submitted That Met QC Criteria: May 9, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Muscle Stretching Exercises
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: LACAP UFPE/UFRN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No