Clinical trial NCT03171012: 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
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Chest Wall Disorder
Quality of Life
Keywords: Muscle Stretching Exercises
Lead sponsor: Universidade Federal do Rio Grande do Norte
Sponsor class: OTHER
First posted: 2017-05-31
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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:

-

Primary outcomes:
measure: Oxygen uptake
timeFrame: Three months total: After 20 sessions of intervention(2 months) and after 1 months without treatment (follow-up)
measure: Balance
timeFrame: Three months total: After 20 sessions of intervention(2 months) and after 1 months without treatment (follow-up)
measure: Quality of life
timeFrame: Three months total: After 20 sessions of intervention(2 months) and after 1 months without treatment (follow-up)
measure: Gait
timeFrame: Three months total: After 20 sessions of intervention(2 months) and after 1 months without treatment (follow-up)
measure: Compartmental volumes of the rib cage
timeFrame: Three months total: After 20 sessions of intervention(2 months) and after 1 months without treatment (follow-up)
Secondary outcomes:
measure: Respiratory function
timeFrame: Three months total:After 20 sessions of intervention(2 months) and after 1 months without treatment (follow-up)
measure: Inspiratory muscle strength
timeFrame: Three months total: After 20 sessions of intervention(2 months) and after 1 months without treatment (follow-up)
measure: Expiratory muscle strength
timeFrame: Three months total: After 20 sessions of intervention(2 months) and after 1 months without treatment (follow-up)
measure: Diaphragmatic thickness
timeFrame: Three months total: After 20 sessions of intervention(2 months) and after 1 months without treatment (follow-up)
measure: Mobility diaphragmatic
timeFrame: Three months total:After 20 sessions of intervention(2 months) and after 1 months without treatment (follow-up)
measure: Oxygen Uptake Efﬁciency Slope
timeFrame: Three months total:After 20 sessions of intervention(2 months) and after 1 months without treatment (follow-up)
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Universidade Federal de Pernambuco
state: Pernambuco
Study officials:
affiliation: Universidade Federal do Rio Grande do Norte
name: RENATA SOUZA, MASTER
role: PRINCIPAL_INVESTIGATOR
References:
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.