Functional DisabilityNCT06690944
Exercise Based on Proprioceptive Neuromuscular Facilitation in Older Individuals
A study testing Proprioceptive Neuromuscular Facilitation in people with Functional Disability and Dynapenia, run by Federal University of Rio Grande do Sul at 1 site in Brazil.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Functional Disability, Dynapenia, Sarcopenia in Elderly
- What is being tested?
- Proprioceptive Neuromuscular Facilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteBrazil
- Study dates
- 23 Mar 2023to 3 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Short Physical Performance Battery score lower than 10 points.
Who cannot join
- Neurodegenerative diseases;
- Illnesses contraindicating exercise (e.g., uncontrolled arrhythmias, acute myocardial infarction);
- Unstable medical condition.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Escola de Educação Física Fisioterapia e Dança - UFRGS
Porto Alegre, Rio Grande do Sul, 90690-200
About this study
Official title: 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?
Read more
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.
Read the 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.
- Conditions
- Functional Disability, Dynapenia, Sarcopenia in Elderly
- Being tested
- Proprioceptive Neuromuscular Facilitation, Physical exercise without proprioceptive neuromuscular facilitation control group
- Keywords
- Frailty, Proprioceptive Neuromuscular Facilitation, Gait, Balance, Sit-Stand, Functionality
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proprioceptive Neuromuscular FacilitationOther
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.
Physical exercise without proprioceptive neuromuscular facilitation control groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Proprioceptive Neuromuscular Facilitation Group | Experimental | 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. Receives: Other: Proprioceptive Neuromuscular Facilitation |
| Physical exercise without proprioceptive neuromuscular facilitation control group | Active comparator | 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. Receives: Other: Physical exercise without proprioceptive neuromuscular facilitation control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short Physical Performance Battery
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).
Measured: Baseline and immediately after the intervention
Secondary outcomes (5)
Timed Up and Go
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.
Measured: Baseline and immediately after the intervention
Handgrip strength
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.
Measured: Baseline and immediately after the intervention
Gait speed
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.
Measured: Baseline and immediately after the intervention
Static balance
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.
Measured: Baseline and immediately after the intervention
Sit-To-Stand
The sit-to-stand test consists of the time spent standing from a chair 5 times.
Measured: Baseline and immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2024
- Study start23 Mar 2023
- Primary completion3 Jun 2024
- Study completion3 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Functional DisabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eduardo Lusa Cadore, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06690944
- Sponsor's protocol ID
- URioGrandePNF
- Status last verified
- Nov 2024
- First submitted
- 11 Nov 2024
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 30582917Alexandre 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.
PubMed 33362441Cadore 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.
PubMed 23327448
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Functioning Adaptations Following a Resisted Functional Exercise Program Based on the Proprioceptive Neuromuscular Facilitation Concept in Older Individuals: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06690944
- Acronym / sponsor ID
- URioGrandePNF
- Conditions
- Functional Disability, Dynapenia, Sarcopenia in Elderly
- Keywords
- Frailty, Proprioceptive Neuromuscular Facilitation, Gait, Balance, Sit-Stand, Functionality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Federal University of Rio Grande do SulUniversity, hospital or other
- Study start
- 23 Mar 2023 (actual)
- Primary completion
- 3 Jun 2024 (actual)
- Study completion
- 3 Jun 2024 (actual)
- First posted
- 15 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Proprioceptive Neuromuscular Facilitation Group | Experimental | Other: Proprioceptive Neuromuscular FacilitationThe 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. |
| Physical exercise without proprioceptive neuromuscular facilitation control group | Active comparator | Other: Physical exercise without proprioceptive neuromuscular facilitation control groupThe 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Short Physical Performance Battery score lower than 10 points.
Key exclusion criteria (3 listed)
- Neurodegenerative diseases;
- Illnesses contraindicating exercise (e.g., uncontrolled arrhythmias, acute myocardial infarction);
- Unstable medical condition.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proprioceptive Neuromuscular FacilitationThe 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. | Other | Proprioceptive Neuromuscular Facilitation Group |
| Physical exercise without proprioceptive neuromuscular facilitation control groupThe 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. | Other | Physical exercise without proprioceptive neuromuscular facilitation control group |
Primary outcome
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).
5 secondary outcomes
Timed Up and Go
Time frame: Baseline and immediately after the intervention
Handgrip strength
Time frame: Baseline and immediately after the intervention
Gait speed
Time frame: Baseline and immediately after the intervention
Static balance
Time frame: Baseline and immediately after the intervention
Sit-To-Stand
Time frame: Baseline and immediately after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
- Background: PubMed 30582917Gunning 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.
- Background: PubMed 33362441Alexandre 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.
- Background: PubMed 23327448Cadore 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proprioceptive Neuromuscular Facilitation in people with Functional Disability and Dynapenia, run by Federal University of Rio Grande do Sul at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short Physical Performance Battery (time frame: Baseline and immediately after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06690944, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2024.