Effect of Nervous System Mobilization on Older Adults' Postural Control

• ClinicalTrials.gov Identifier: NCT03493373
• Recruitment Status: Completed
• First Posted: April 10, 2018
• Last Update Posted: March 26, 2019
• Sponsor: Aveiro University
• Information provided by (Responsible Party): Anabela G Silva, Aveiro University

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Older Adults	Other: Exercise; Other: Neural mobilization	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 26 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effect of Nervous System Mobilization on Older Adults' Postural Control
• Actual Study Start Date: April 15, 2018
• Actual Primary Completion Date: December 15, 2018
• Actual Study Completion Date: December 21, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Gait velocity [ Time Frame: Baseline ]
   Participants are asked to walk at normal gait velocity over 4 meters and gait velocity is calculated
2. Gait velocity [ Time Frame: 9 weeks ]
   Participants are asked to walk at normal gait velocity over 4 meters and gait velocity is calculated
3. Gait velocity [ Time Frame: 3 months ]
   Participants are asked to walk at normal gait velocity over 4 meters and gait velocity is calculated

Secondary Outcome Measures :

1. Pain intensity [ Time Frame: Baseline ]
   Pain intensity measured using a vertical numeric rating scale (Range: 0 to 10 and higher values are indicative of higher pain intensity)
2. Pain intensity [ Time Frame: 9 weeks ]
   Pain intensity measured using a vertical numeric rating scale (Range: 0 to 10 and higher values are indicative of higher pain intensity)
3. Pain intensity [ Time Frame: 3 months ]
   Pain intensity measured using a vertical numeric rating scale (Range: 0 to 10 and higher values are indicative of higher pain intensity)
4. Pain location [ Time Frame: Baseline ]
   Measured using a body chart (a graphic representation of the body) where participants identify painful body sites
5. Pain location [ Time Frame: 9 weeks ]
   Measured using a body chart (a graphic representation of the body) where participants identify painful body sites
6. Pain location [ Time Frame: 3 months ]
   Measured using a body chart (a graphic representation of the body) where participants identify painful body sites
7. Depressive symptoms [ Time Frame: Baseline ]
   Measured using the 15-itens Geriatric Depression Scale (range: 0-15; participants who score 5 or more have depression)
8. Depressive symptoms [ Time Frame: 9 weeks ]
   Measured using the 15-itens Geriatric Depression Scale (range: 0-15; participants who score 5 or more have depression)
9. Depressive symptoms [ Time Frame: 3 months ]
   Measured using the 15-itens Geriatric Depression Scale (range: 0-15; participants who score 5 or more have depression)
10. Balance [ Time Frame: Baseline ]
    Participants are asked to maintain a tandem/semi-tandem position for up to 30 seconds.
11. Balance [ Time Frame: 9 weeks ]
    Participants are asked to maintain a tandem/semi-tandem position for up to 30 seconds.
12. Balance [ Time Frame: 3 months ]
    Participants are asked to maintain a tandem/semi-tandem position for up to 30 seconds.
13. Timed up and go test [ Time Frame: Baseline ]
    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.
14. Timed up and go test [ Time Frame: 9 weeks ]
    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.
15. Timed up and go test [ Time Frame: 3 months ]
    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.

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Locations

Portugal

Lar Santa Catarina do Reboleiro

Guarda, Portugal, 3810-193

Lar da Santa Cruz da Beselga

Guarda, Portugal

Sponsors and Collaborators

Aveiro University

More Information

• Responsible Party: Anabela G Silva, Assistant Professor, Aveiro University
• ClinicalTrials.gov Identifier: NCT03493373
• Other Study ID Numbers: 5/2018
• First Posted: April 10, 2018
• Last Update Posted: March 26, 2019
• Last Verified: March 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No