Older AdultsNCT03493373
Effect of Nervous System Mobilization on Older Adults' Postural Control
A study testing Exercise and Neural mobilization in people with Older Adults, run by Aveiro University at 2 sites in Portugal.
Trial summary
This study aims to compare the effectiveness of nervous system mobilization and exercise with exercise only on institutionalized older adults' postural control. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Older Adults
- What is being tested?
- Exercise and Neural mobilization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 2 sitesPortugal
- Study dates
- 15 Apr 2018to 21 Dec 2018
- 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
- 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
Who cannot join
- inability to understand study aims.
Trial locations and contacts
2 sites in 1 country.
Portugal2 sites
Lar Santa Catarina do Reboleiro
Guarda, 3810-193
Lar da Santa Cruz da Beselga
Guarda
About this study
This study aims to compare the effectiveness of nervous system mobilization and exercise with exercise only on institutionalized older adults' postural control.
Read the 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.
- Conditions
- Older Adults
- Being tested
- Exercise, Neural mobilization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
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 mobilizationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise and nervous system mobilization | Experimental | This group will receive neural mobilization and therapeutic exercise: two sessions of 60 minutes during 8 weeks. Receives: Other: Exercise; Other: Neural mobilization |
| Exercise | Experimental | This group will receive therapeutic exercise: two sessions of 60 minutes during 8 weeks. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait velocity
Participants are asked to walk at normal gait velocity over 4 meters and gait velocity is calculated
Measured: Baseline
Gait velocity
Participants are asked to walk at normal gait velocity over 4 meters and gait velocity is calculated
Measured: 9 weeks
Gait velocity
Participants are asked to walk at normal gait velocity over 4 meters and gait velocity is calculated
Measured: 3 months
Secondary outcomes (15)
Pain intensity
Pain intensity measured using a vertical numeric rating scale (Range: 0 to 10 and higher values are indicative of higher pain intensity)
Measured: 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)
Measured: 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)
Measured: 3 months
Pain location
Measured using a body chart (a graphic representation of the body) where participants identify painful body sites
Measured: Baseline
Pain location
Measured using a body chart (a graphic representation of the body) where participants identify painful body sites
Measured: 9 weeks
Pain location
Measured using a body chart (a graphic representation of the body) where participants identify painful body sites
Measured: 3 months
Depressive symptoms
Measured using the 15-itens Geriatric Depression Scale (range: 0-15; participants who score 5 or more have depression)
Measured: Baseline
Depressive symptoms
Measured using the 15-itens Geriatric Depression Scale (range: 0-15; participants who score 5 or more have depression)
Measured: 9 weeks
Depressive symptoms
Measured using the 15-itens Geriatric Depression Scale (range: 0-15; participants who score 5 or more have depression)
Measured: 3 months
Balance
Participants are asked to maintain a tandem/semi-tandem position for up to 30 seconds.
Measured: Baseline
Balance
Participants are asked to maintain a tandem/semi-tandem position for up to 30 seconds.
Measured: 9 weeks
Balance
Participants are asked to maintain a tandem/semi-tandem position for up to 30 seconds.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2018
- Study start15 Apr 2018
- Primary completion15 Dec 2018
- Study completion21 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Older AdultsStudies 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
- Participant, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aveiro University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anabela G Silva, Aveiro University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03493373
- Sponsor's protocol ID
- 5/2018
- Status last verified
- Mar 2019
- First submitted
- 4 Apr 2018
- Last updated
- 26 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Nervous System Mobilization on Older Adults' Postural Control
- ClinicalTrials.gov ID
- NCT03493373
- Acronym / sponsor ID
- 5/2018
- Conditions
- Older Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Aveiro UniversityUniversity, hospital or other
- Study start
- 15 Apr 2018 (actual)
- Primary completion
- 15 Dec 2018 (actual)
- Study completion
- 21 Dec 2018 (actual)
- First posted
- 10 Apr 2018 (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.
This study aims to compare the effectiveness of nervous system mobilization and exercise with exercise only on institutionalized older adults' postural control.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise and nervous system mobilization | Experimental | Other: Exercise, Other: Neural mobilizationThis group will receive neural mobilization and therapeutic exercise: two sessions of 60 minutes during 8 weeks. |
| Exercise | Experimental | Other: ExerciseThis group will receive therapeutic exercise: two sessions of 60 minutes during 8 weeks. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- inability to understand study aims.
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 |
|---|---|---|
| ExerciseThe 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 | Exercise, Exercise and nervous system mobilization |
| Neural mobilizationNeural gliding mobilization will target mainly the lower limb nerves and will be performed in series of 10 repetitions with 1 minute interval between series. | Other | Exercise and nervous system mobilization |
Primary outcome
Gait velocity
Time frame: Baseline
Participants are asked to walk at normal gait velocity over 4 meters and gait velocity is calculated
Gait velocity
Time frame: 9 weeks
Participants are asked to walk at normal gait velocity over 4 meters and gait velocity is calculated
Gait velocity
Time frame: 3 months
Participants are asked to walk at normal gait velocity over 4 meters and gait velocity is calculated
15 secondary outcomes
Pain intensity
Time frame: Baseline
Pain intensity
Time frame: 9 weeks
Pain intensity
Time frame: 3 months
Pain location
Time frame: Baseline
Pain location
Time frame: 9 weeks
Pain location
Time frame: 3 months
Depressive symptoms
Time frame: Baseline
Depressive symptoms
Time frame: 9 weeks
Depressive symptoms
Time frame: 3 months
Balance
Time frame: Baseline
Balance
Time frame: 9 weeks
Balance
Time frame: 3 months
Timed up and go test
Time frame: Baseline
Timed up and go test
Time frame: 9 weeks
Timed up and go test
Time frame: 3 months
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 26 Mar 2019.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Neural mobilization in people with Older Adults, run by Aveiro University at 2 sites in Portugal.
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 3 inclusion and 1 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 26 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Portugal. 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?
Gait velocity (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Mar 2019.