- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06690944
Exercise Based on Proprioceptive Neuromuscular Facilitation in Older Individuals
Physical Functioning Adaptations Following a Resisted Functional Exercise Program Based on the Proprioceptive Neuromuscular Facilitation Concept in Older Individuals: a Randomized Clinical Trial
The goal of this clinical trial was to determine whether an intervention using resisted sit-to-stand and walking exercises with Proprioceptive Neuromuscular Facilitation (PNF) techniques improved gait and sit-to-stand in older individuals with poor functional capacity compared to a control group that performed the same activities, but without manual resistance. The main questions it aimed to answer were:
Did an exercise program based on the PNF concept improve functional capacity and strength performance?
Was there a difference between an exercise program with or without PNF techniques on functional capacity and strength in older adults?
Researchers compared the effects of an exercise program based on the PNF concept to a similar exercise training without manual resistance on functional capacity and strength performance.
Participants participated in an intervention using resisted sit-to-stand and walking exercises with or without PNF and performed functional capacity and strength tests at the beginning and end of the intervention.
Study Overview
Status
Conditions
Detailed Description
The proposal consisted of investigating an exercise intervention based on the Proprioceptive Neuromuscular Facilitation concept (PFNG), compared to a control group (CG), which performed the same exercises as PNFG under a therapist's supervision, but without resistance imposed by the therapist's hands as in PFNG, in older individuals.
Before data collection, individuals participated in a familiarization procedure for each test. Each specific test was conducted on the same equipment with identical participant/equipment positioning. Functional assessment and intervention were conducted at the participants' residences.
The CG intervention consisted of the same activities carried out in the PNFG during Stages 1 and 2, for the same amount of minutes, sessions, and weeks. However, the CG intervention did not include specific techniques and basic principles (i.e., approximation and optimal resistance) and procedures of the PNF concept. The activities were instructed and supervised by a trained professional through verbal commands. The professional was in a stand-by assistant position to prevent accidents. Each intervention lasted 30 minutes and took place twice a week, for 4 weeks, totaling 8 meetings. The interventions were supervised by researchers blinded to pre-intervention assessment results and randomly assigned for both PNF and control groups. The researchers responsible for the interventions were physical therapists with basic IPNFA® (International Proprioceptive Neuromuscular Facilitation Association) instruction.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
RS
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Porto Alegre, RS, Brazil, 90690-200
- Escola de Educação Física Fisioterapia e Dança - UFRGS
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Short Physical Performance Battery score lower than 10 points.
Exclusion Criteria:
- Neurodegenerative diseases;
- Illnesses contraindicating exercise (e.g., uncontrolled arrhythmias, acute myocardial infarction);
- Unstable medical condition.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Proprioceptive Neuromuscular Facilitation Group
The Proprioceptive Neuromuscular Facilitation group (PNFG) intervention consisted of applying PNF concept exercises and techniques related to facilitating sitting and walking, carried out by a therapist with basic IPNFA® (International Proprioceptive Neuromuscular Facilitation Association) instruction.
The PNF intervention was divided into two stages: Stage 1: which consisted of facilitating stability and controlled mobility of the initial position and phases 1, 2, 3, of the sit-up.
At the initial position, we applied PNF stabilizing reversals technique for 2 minutes, to stimulate stability in the upright sitting position.
In phase 1, we applied PNF to stimulate controlled mobility of the anterior inclination of the erect trunk.
In Phase 2, to improve the concentric and eccentric control of lower limb extensor muscles and, in Phase 3 to improve the stability in an upright position again.
Stage 2: consists of facilitating activities related to gait.
|
The following basic principles and procedures were emphasized when applying the techniques: manual contact, resistance, approximation, verbal commands, and therapist's body mechanics.
During stages 1 and 2 of the intervention, the amount of PNF optimal resistance used was necessary to maintain a stable and safe position, with good body alignment, in a manner that produced coordinated movements to generate appropriate motor learning.
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Active Comparator: Physical exercise without proprioceptive neuromuscular facilitation control group
The physical exercise without proprioceptive neuromuscular facilitation control group (CG) Intervention consisted of the same activities carried out in the proprioceptive neuromuscular facilitation group (PNFG) during Stages 1 and 2, during the same amount of minutes, sessions, and weeks; however, CG intervention did not include specific techniques and basic principles (i.e.
approximation and optimal resistance) and procedures of the PNF concept.
The activities were instructed and supervised by a trained professional through verbal command.
The professional was at stand-by assistant position to prevent accidents.
|
The physical exercise without proprioceptive neuromuscular facilitation control group (CG) intervention consisted of the same activities carried out in the proprioceptive neuromuscular facilitation (PNF) group during Stages 1 and 2, during the same amount of minutes, sessions, and weeks; however, CG intervention did not include specific techniques and basic principles (i.e.
approximation and optimal resistance) and procedures of the PNF concept.
The activities were instructed and supervised by a trained professional through verbal command.
The professional was at stand-by assistant position to prevent accidents.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Short Physical Performance Battery
Time Frame: Baseline and immediately after the intervention
|
Short Physical Performance Battery (SPPB) includes usual walking speed over 4 meters, balance, and five times sit-to-stand.
The sum of the three individual categorical scores yielded the final SPPB score, which ranged from 0 (worst) to 12 (best).
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Baseline and immediately after the intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Timed Up and Go
Time Frame: Baseline and immediately after the intervention
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The Timed Up and Go test consists of measuring the time required to perform the task of standing from a chair, walking 3 meters, turning, going back, and sitting down on the chair.
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Baseline and immediately after the intervention
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Handgrip strength
Time Frame: Baseline and immediately after the intervention
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Handgrip strength is measured using a hand dynamometer (Jamar Hydraulic Hand Dynamometer).
The dynamometer is squeezed twice with each hand while the participant is seated.
The upper arm is positioned close to the body with the elbow at a 90° angle.
The higher score is used, provided the difference does not exceed 10%; otherwise, a third measurement is taken.
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Baseline and immediately after the intervention
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Gait speed
Time Frame: Baseline and immediately after the intervention
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Gait speed is assessed through a 4-meter walking test.
Participants are asked to walk 4 meters at their usual speed on a horizontal walkway.
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Baseline and immediately after the intervention
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Static balance
Time Frame: Baseline and immediately after the intervention
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Static balance is assessed through 10-second hold parallel feet, semi-tandem, and tandem positions.
Participants progress to the hardest test only if they succeed in the easiest.
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Baseline and immediately after the intervention
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Sit-To-Stand
Time Frame: Baseline and immediately after the intervention
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The sit-to-stand test consists of the time spent standing from a chair 5 times.
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Baseline and immediately after the intervention
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Collaborators and Investigators
Publications and helpful links
General Publications
- Cadore EL, Rodriguez-Manas L, Sinclair A, Izquierdo M. Effects of different exercise interventions on risk of falls, gait ability, and balance in physically frail older adults: a systematic review. Rejuvenation Res. 2013 Apr;16(2):105-14. doi: 10.1089/rej.2012.1397.
- Gunning E, Uszynski MK. Effectiveness of the Proprioceptive Neuromuscular Facilitation Method on Gait Parameters in Patients With Stroke: A Systematic Review. Arch Phys Med Rehabil. 2019 May;100(5):980-986. doi: 10.1016/j.apmr.2018.11.020. Epub 2018 Dec 22.
- Alexandre de Assis IS, Luvizutto GJ, Bruno ACM, Sande de Souza LAP. The Proprioceptive Neuromuscular Facilitation Concept in Parkinson Disease: A Systematic Review and Meta-Analysis. J Chiropr Med. 2020 Sep;19(3):181-187. doi: 10.1016/j.jcm.2020.07.003. Epub 2020 Dec 15.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- URioGrandePNF
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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