Addition of Proprioceptive Neuromuscular Facilitation to Cardio Respiratory Training Post Stroke

NCT ID: NCT03171012

Last Updated: 2023-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-19

Study Completion Date

2026-06-30

Brief Summary

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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

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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.

Conditions

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Stroke Chest Wall Disorder Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
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.

Study Groups

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Lower limbs CRT+ PNF

Lower Limbs Cardiorespiratory training associated with Proprioceptive Neuromuscular Facilitation

Group Type EXPERIMENTAL

Lower limbs CRT

Intervention Type OTHER

cycle ergometer for lower limbs

Proprioceptive Neuromuscular Facilitation

Intervention Type OTHER

Proprioceptive Neuromuscular Facilitation patterns will be performed in seated, dorsal, ventral and side.

Lower limbs CRT + respiration

Lower limbs Cardiorespiratory training associated with respiration

Group Type ACTIVE_COMPARATOR

Lower limbs CRT

Intervention Type OTHER

cycle ergometer for lower limbs

respiration

Intervention Type OTHER

respiration

Upper limbs CRT + PNF

Upper limbs Cardiorespiratory training associated with Proprioceptive Neuromuscular Facilitation

Group Type EXPERIMENTAL

Upper limbs CRT

Intervention Type OTHER

cycle ergometer for upper limbs

Proprioceptive Neuromuscular Facilitation

Intervention Type OTHER

Proprioceptive Neuromuscular Facilitation patterns will be performed in seated, dorsal, ventral and side.

Upper limbs CRT + respiration

Upper limbs Cardiorespiratory training associated with respiration

Group Type ACTIVE_COMPARATOR

Upper limbs CRT

Intervention Type OTHER

cycle ergometer for upper limbs

respiration

Intervention Type OTHER

respiration

Interventions

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Lower limbs CRT

cycle ergometer for lower limbs

Intervention Type OTHER

Upper limbs CRT

cycle ergometer for upper limbs

Intervention Type OTHER

Proprioceptive Neuromuscular Facilitation

Proprioceptive Neuromuscular Facilitation patterns will be performed in seated, dorsal, ventral and side.

Intervention Type OTHER

respiration

respiration

Intervention Type OTHER

Eligibility Criteria

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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

\-
Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidade Federal do Rio Grande do Norte

OTHER

Sponsor Role lead

Responsible Party

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Renata JanaĆ­na Pereira de Souza

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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RENATA SOUZA, MASTER

Role: PRINCIPAL_INVESTIGATOR

Universidade Federal do Rio Grande do Norte

Locations

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Universidade Federal de Pernambuco

Recife, Pernambuco, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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RENATA SOUZA, MASTER

Role: CONTACT

55 81 999069957

Facility Contacts

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Renata Souza

Role: primary

+55 81 999069957

References

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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.

Reference Type DERIVED
PMID: 32059691 (View on PubMed)

Other Identifiers

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LACAP UFPE/UFRN

Identifier Type: -

Identifier Source: org_study_id

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