NCT06690944

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 23, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 3, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 3, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 11, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 15, 2024

Completed
Last Updated

November 19, 2024

Status Verified

November 1, 2024

Enrollment Period

1.2 years

First QC Date

November 11, 2024

Last Update Submit

November 16, 2024

Conditions

Keywords

FrailtyProprioceptive Neuromuscular FacilitationGaitBalanceSit-StandFunctionality

Outcome Measures

Primary Outcomes (1)

  • 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).

    Baseline and immediately after the intervention

Secondary Outcomes (5)

  • Timed Up and Go

    Baseline and immediately after the intervention

  • Handgrip strength

    Baseline and immediately after the intervention

  • Gait speed

    Baseline and immediately after the intervention

  • Static balance

    Baseline and immediately after the intervention

  • Sit-To-Stand

    Baseline and immediately after the intervention

Study Arms (2)

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.

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.

Other: Physical exercise without proprioceptive neuromuscular facilitation control group

Interventions

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.

Proprioceptive Neuromuscular Facilitation Group

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.

Physical exercise without proprioceptive neuromuscular facilitation control group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Short Physical Performance Battery score lower than 10 points.

You may not qualify if:

  • Neurodegenerative diseases;
  • Illnesses contraindicating exercise (e.g., uncontrolled arrhythmias, acute myocardial infarction);
  • Unstable medical condition.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Escola de Educação Física Fisioterapia e Dança - UFRGS

Porto Alegre, Rio Grande do Sul, 90690-200, Brazil

Location

Related Publications (3)

  • 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.

    PMID: 30582917BACKGROUND
  • 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.

    PMID: 33362441BACKGROUND
  • 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.

    PMID: 23327448BACKGROUND

MeSH Terms

Conditions

Frailty

Interventions

Muscle Stretching ExercisesExercise

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 11, 2024

First Posted

November 15, 2024

Study Start

March 23, 2023

Primary Completion

June 3, 2024

Study Completion

June 3, 2024

Last Updated

November 19, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
After the end of the study, no end date for sharing IPD was set.
Access Criteria
Researchers affiliated with recognized research institutions, with a research project approved by an ethics committee for the protection of human subjects, will have access to the following data: the study protocol, statistical analysis plan, informed consent form, clinical study report, and analytic code. They can request access by emailing the principal investigator with all necessary information. After review, a data table will be sent.

Locations