Addition of Proprioceptive Neuromuscular Facilitation to Cardio Respiratory Training Post Stroke
Primary Purpose
Stroke, Chest Wall Disorder, Quality of Life
Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Lower limbs CRT
Upper limbs CRT
Proprioceptive Neuromuscular Facilitation
respiration
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring Muscle Stretching Exercises
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:
-
Sites / Locations
- Universidade Federal de PernambucoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Experimental
Active Comparator
Arm Label
Lower limbs CRT+ PNF
Lower limbs CRT + respiration
Upper limbs CRT + PNF
Upper limbs CRT + respiration
Arm Description
Lower Limbs Cardiorespiratory training associated with Proprioceptive Neuromuscular Facilitation
Lower limbs Cardiorespiratory training associated with respiration
Upper limbs Cardiorespiratory training associated with Proprioceptive Neuromuscular Facilitation
Upper limbs Cardiorespiratory training associated with respiration
Outcomes
Primary Outcome Measures
Oxygen uptake
maximum oxygen volume consumed during the 6-minute walk test
Balance
The scale assesses the balance based on 14 common items of day-to-day.
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).
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.
Compartmental volumes of the rib cage
Analysis of the kinematics of the thoracic wall through the optical-electronic plethysmograph
Secondary Outcome Measures
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).
Inspiratory muscle strength
Manovacuometry: Maximal Inspiratory pressure (MIP), Measured in centimeters of water
Expiratory muscle strength
Manovacuometry: maximal expiratory pressure (MEP), Measured in centimeters of water
Diaphragmatic thickness
Measurement of the diaphragmatic thickness from the middle of the pleural line to the middle of the peritoneal line.
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.
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.
Full Information
NCT ID
NCT03171012
First Posted
May 23, 2017
Last Updated
May 9, 2023
Sponsor
Universidade Federal do Rio Grande do Norte
1. Study Identification
Unique Protocol Identification Number
NCT03171012
Brief Title
Addition of Proprioceptive Neuromuscular Facilitation to Cardio Respiratory Training Post Stroke
Official Title
Proprioceptive Neuromuscular Facilitation Repercussions Associated With Cardiorespiratory Training in Postal Individuals Stroke to the Functions Motor, Respiratory and Quality of Life: Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 19, 2017 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
June 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal do Rio Grande do Norte
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Chest Wall Disorder, Quality of Life
Keywords
Muscle Stretching Exercises
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Forty individuals into four groups: Experimental Lower Limbs (LL's CRT with PNF); Group control Lower Limbs (LL's CRT with respiration). Experimental Upper Limbs (UP's CRT with PNF) and Group control Upper Limbs (UP's CRT with respiration). Individuals will be assessed before and immediately after 20 program sessions and one month after the end of treatment.
The treatment program will have the full 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 with PNF or to respiration, being performed in 20 Sessions three times a week. For therapy with the CRT used the cycle ergometer for lower or upper limbs, Based on the criteria of the ACSM and monitoring Constant blood pressure, oxygen saturation and perceived exertion. The PNF patterns will be performed in seated, dorsal, ventral and Side.
Masking
ParticipantInvestigator
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.
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lower limbs CRT+ PNF
Arm Type
Experimental
Arm Description
Lower Limbs Cardiorespiratory training associated with Proprioceptive Neuromuscular Facilitation
Arm Title
Lower limbs CRT + respiration
Arm Type
Active Comparator
Arm Description
Lower limbs Cardiorespiratory training associated with respiration
Arm Title
Upper limbs CRT + PNF
Arm Type
Experimental
Arm Description
Upper limbs Cardiorespiratory training associated with Proprioceptive Neuromuscular Facilitation
Arm Title
Upper limbs CRT + respiration
Arm Type
Active Comparator
Arm Description
Upper limbs Cardiorespiratory training associated with respiration
Intervention Type
Other
Intervention Name(s)
Lower limbs CRT
Intervention Description
cycle ergometer for lower limbs
Intervention Type
Other
Intervention Name(s)
Upper limbs CRT
Intervention Description
cycle ergometer for upper limbs
Intervention Type
Other
Intervention Name(s)
Proprioceptive Neuromuscular Facilitation
Intervention Description
Proprioceptive Neuromuscular Facilitation patterns will be performed in seated, dorsal, ventral and side.
Intervention Type
Other
Intervention Name(s)
respiration
Intervention Description
respiration
Primary Outcome Measure Information:
Title
Oxygen uptake
Description
maximum oxygen volume consumed during the 6-minute walk test
Time Frame
Three months total: After 20 sessions of intervention(2 months) and after 1 months without treatment (follow-up)
Title
Balance
Description
The scale assesses the balance based on 14 common items of day-to-day.
Time Frame
Three months total: After 20 sessions of intervention(2 months) and after 1 months without treatment (follow-up)
Title
Quality of life
Description
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).
Time Frame
Three months total: After 20 sessions of intervention(2 months) and after 1 months without treatment (follow-up)
Title
Gait
Description
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.
Time Frame
Three months total: After 20 sessions of intervention(2 months) and after 1 months without treatment (follow-up)
Title
Compartmental volumes of the rib cage
Description
Analysis of the kinematics of the thoracic wall through the optical-electronic plethysmograph
Time Frame
Three months total: After 20 sessions of intervention(2 months) and after 1 months without treatment (follow-up)
Secondary Outcome Measure Information:
Title
Respiratory function
Description
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).
Time Frame
Three months total:After 20 sessions of intervention(2 months) and after 1 months without treatment (follow-up)
Title
Inspiratory muscle strength
Description
Manovacuometry: Maximal Inspiratory pressure (MIP), Measured in centimeters of water
Time Frame
Three months total: After 20 sessions of intervention(2 months) and after 1 months without treatment (follow-up)
Title
Expiratory muscle strength
Description
Manovacuometry: maximal expiratory pressure (MEP), Measured in centimeters of water
Time Frame
Three months total: After 20 sessions of intervention(2 months) and after 1 months without treatment (follow-up)
Title
Diaphragmatic thickness
Description
Measurement of the diaphragmatic thickness from the middle of the pleural line to the middle of the peritoneal line.
Time Frame
Three months total: After 20 sessions of intervention(2 months) and after 1 months without treatment (follow-up)
Title
Mobility diaphragmatic
Description
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.
Time Frame
Three months total:After 20 sessions of intervention(2 months) and after 1 months without treatment (follow-up)
Title
Oxygen Uptake Efficiency Slope
Description
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.
Time Frame
Three months total:After 20 sessions of intervention(2 months) and after 1 months without treatment (follow-up)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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:
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
RENATA SOUZA, MASTER
Phone
55 81 999069957
Email
FTRJPS@GMAIL.COM
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
RENATA SOUZA, MASTER
Organizational Affiliation
Universidade Federal do Rio Grande do Norte
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidade Federal de Pernambuco
City
Recife
State/Province
Pernambuco
ZIP/Postal Code
50740 - 560
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Renata Souza
Phone
+55 81 999069957
Email
ftrjps@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32059691
Citation
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.
Results Reference
derived
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Addition of Proprioceptive Neuromuscular Facilitation to Cardio Respiratory Training Post Stroke
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