Effect of Nervous System Mobilization on Older Adults' Postural Control

This study aims to compare the effectiveness of nervous system mobilization and exercise with exercise only on institutionalized older adults' postural control.

Study Overview

• Status: Completed
• Conditions: Older Adults
• Intervention / Treatment: Other: Exercise; Other: Neural mobilization

Detailed Description

It is anticipated that 26 institutionalized older adults will be randomly allocated to receive either exercise and neural mobilization (n=13) or exercise only (n=13).

Data on pain intensity (a vertical numeric rating scale) and location (body chart), depression (Geriatric Depression Scale), balance, hand grip strength, timed up and go and gait velocity will be collected at baseline, end of treatment and at 3 months follow up.

Statistical analysis will be performed using a mixed-methods ANOVA.

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Portugal
  • Guarda, Portugal, 3810-193
    • Lar Santa Catarina do Reboleiro
  • Guarda, Portugal
    • Lar da Santa Cruz da Beselga

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• be 65 years of age or older;
• to have independent gait with or without technical aid;
• have indication of the institution's doctor for participation in the study

Exclusion Criteria:

• inability to understand study aims.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise and nervous system mobilization; This group will receive neural mobilization and therapeutic exercise: two sessions of 60 minutes during 8 weeks.	Other: Exercise; The exercise program will consist of: 1) warm up - consisting of stretches of large muscle groups of the upper limbs, lower limbs and trunk and by general mobility exercises; 2) strength training of moderate intensity; 3) balance training; 4) Cooling - will consist of performing overall stretching combined with deep breathing.; Other: Neural mobilization; Neural gliding mobilization will target mainly the lower limb nerves and will be performed in series of 10 repetitions with 1 minute interval between series.
Experimental: Exercise; This group will receive therapeutic exercise: two sessions of 60 minutes during 8 weeks.	Other: Exercise; The exercise program will consist of: 1) warm up - consisting of stretches of large muscle groups of the upper limbs, lower limbs and trunk and by general mobility exercises; 2) strength training of moderate intensity; 3) balance training; 4) Cooling - will consist of performing overall stretching combined with deep breathing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gait velocity	Participants are asked to walk at normal gait velocity over 4 meters and gait velocity is calculated	Baseline
Gait velocity	Participants are asked to walk at normal gait velocity over 4 meters and gait velocity is calculated	9 weeks
Gait velocity	Participants are asked to walk at normal gait velocity over 4 meters and gait velocity is calculated	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity	Pain intensity measured using a vertical numeric rating scale (Range: 0 to 10 and higher values are indicative of higher pain intensity)	Baseline
Pain intensity	Pain intensity measured using a vertical numeric rating scale (Range: 0 to 10 and higher values are indicative of higher pain intensity)	9 weeks
Pain intensity	Pain intensity measured using a vertical numeric rating scale (Range: 0 to 10 and higher values are indicative of higher pain intensity)	3 months
Pain location	Measured using a body chart (a graphic representation of the body) where participants identify painful body sites	Baseline
Pain location	Measured using a body chart (a graphic representation of the body) where participants identify painful body sites	9 weeks
Pain location	Measured using a body chart (a graphic representation of the body) where participants identify painful body sites	3 months
Depressive symptoms	Measured using the 15-itens Geriatric Depression Scale (range: 0-15; participants who score 5 or more have depression)	Baseline
Depressive symptoms	Measured using the 15-itens Geriatric Depression Scale (range: 0-15; participants who score 5 or more have depression)	9 weeks
Depressive symptoms	Measured using the 15-itens Geriatric Depression Scale (range: 0-15; participants who score 5 or more have depression)	3 months
Balance	Participants are asked to maintain a tandem/semi-tandem position for up to 30 seconds.	Baseline
Balance	Participants are asked to maintain a tandem/semi-tandem position for up to 30 seconds.	9 weeks
Balance	Participants are asked to maintain a tandem/semi-tandem position for up to 30 seconds.	3 months
Timed up and go test	Get up from a chair, walk 3 meters, go back to the chair and sit back. The amount of time that each participant takes to perform the task is taken.	Baseline
Timed up and go test	Get up from a chair, walk 3 meters, go back to the chair and sit back.The amount of time that each participant takes to perform the task is taken.	9 weeks
Timed up and go test	Get up from a chair, walk 3 meters, go back to the chair and sit back. The amount of time that each participant takes to perform the task is taken.	3 months

Collaborators and Investigators

• Sponsor: Aveiro University

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2018
• Primary Completion (Actual): December 15, 2018
• Study Completion (Actual): December 21, 2018

Study Registration Dates

• First Submitted: April 4, 2018
• First Submitted That Met QC Criteria: April 4, 2018
• First Posted (Actual): April 10, 2018

Study Record Updates

• Last Update Posted (Actual): March 26, 2019
• Last Update Submitted That Met QC Criteria: March 25, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 5/2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No