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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03493373
Other study ID # 5/2018
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 15, 2018
Est. completion date December 21, 2018

Study information

Verified date March 2019
Source Aveiro University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 26
Est. completion date December 21, 2018
Est. primary completion date December 15, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
Portugal Lar da Santa Cruz da Beselga Guarda
Portugal Lar Santa Catarina do Reboleiro Guarda

Sponsors (1)

Lead Sponsor Collaborator
Aveiro University

Country where clinical trial is conducted

Portugal, 

Outcome

Type Measure Description Time frame Safety issue
Primary Gait velocity Participants are asked to walk at normal gait velocity over 4 meters and gait velocity is calculated Baseline
Primary Gait velocity Participants are asked to walk at normal gait velocity over 4 meters and gait velocity is calculated 9 weeks
Primary Gait velocity Participants are asked to walk at normal gait velocity over 4 meters and gait velocity is calculated 3 months
Secondary 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
Secondary 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
Secondary 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
Secondary Pain location Measured using a body chart (a graphic representation of the body) where participants identify painful body sites Baseline
Secondary Pain location Measured using a body chart (a graphic representation of the body) where participants identify painful body sites 9 weeks
Secondary Pain location Measured using a body chart (a graphic representation of the body) where participants identify painful body sites 3 months
Secondary Depressive symptoms Measured using the 15-itens Geriatric Depression Scale (range: 0-15; participants who score 5 or more have depression) Baseline
Secondary Depressive symptoms Measured using the 15-itens Geriatric Depression Scale (range: 0-15; participants who score 5 or more have depression) 9 weeks
Secondary Depressive symptoms Measured using the 15-itens Geriatric Depression Scale (range: 0-15; participants who score 5 or more have depression) 3 months
Secondary Balance Participants are asked to maintain a tandem/semi-tandem position for up to 30 seconds. Baseline
Secondary Balance Participants are asked to maintain a tandem/semi-tandem position for up to 30 seconds. 9 weeks
Secondary Balance Participants are asked to maintain a tandem/semi-tandem position for up to 30 seconds. 3 months
Secondary 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
Secondary 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
Secondary 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
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