Addition of Proprioceptive Neuromuscular Facilitation to Cardio Respiratory Training Post Stroke

NCT03171012 | Recruiting DMC

• 1 other identifier: LACAP UFPE/UFRN
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Chest Wall Disorder; Quality of Life

Keywords

Muscle Stretching Exercises

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (6)

• 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)

Study Arms (4)

Lower limbs CRT+ PNF

EXPERIMENTAL

Lower Limbs Cardiorespiratory training associated with Proprioceptive Neuromuscular Facilitation

Other: Lower limbs CRT; Other: Proprioceptive Neuromuscular Facilitation

Lower limbs CRT + respiration

ACTIVE COMPARATOR

Lower limbs Cardiorespiratory training associated with respiration

Other: Lower limbs CRT; Other: respiration

Upper limbs CRT + PNF

EXPERIMENTAL

Upper limbs Cardiorespiratory training associated with Proprioceptive Neuromuscular Facilitation

Other: Upper limbs CRT; Other: Proprioceptive Neuromuscular Facilitation

Upper limbs CRT + respiration

ACTIVE COMPARATOR

Upper limbs Cardiorespiratory training associated with respiration

Other: Upper limbs CRT; Other: respiration

Interventions

Lower limbs CRT OTHER

cycle ergometer for lower limbs

Lower limbs CRT + respiration; Lower limbs CRT+ PNF

Upper limbs CRT OTHER

cycle ergometer for upper limbs

Upper limbs CRT + PNF; Upper limbs CRT + respiration

Proprioceptive Neuromuscular Facilitation OTHER

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

Lower limbs CRT+ PNF; Upper limbs CRT + PNF

respiration OTHER

respiration

Lower limbs CRT + respiration; Upper limbs CRT + respiration

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Universidade Federal do Rio Grande do Norte: lead

Study Sites (1)

Universidade Federal de Pernambuco

Recife, Pernambuco, 50740 - 560, Brazil

RECRUITING

Related Publications (1)

• 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.

  PMID: 32059691 DERIVED

MeSH Terms

Conditions

Stroke

Interventions

Muscle Stretching Exercises; Respiration

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• RENATA SOUZA, MASTER

  Universidade Federal do Rio Grande do Norte

  PRINCIPAL INVESTIGATOR

Central Study Contacts

RENATA SOUZA, MASTER

CONTACT

55 81 999069957; FTRJPS@GMAIL.COM

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: May 23, 2017
• First Posted: May 31, 2017
• Study Start: June 19, 2017
• Primary Completion: December 1, 2024
• Study Completion (Estimated): June 1, 2026
• Last Updated: May 11, 2023

Record last verified: 2023-05

Locations

BR (1)