Functional InsufficiencyNCT02487667
Therapeutic Exercise Training in the Elderly
A study testing Therapeutic exercise by fitness machines in people with Functional Insufficiency and Aging, run by Universidad de Zaragoza at 1 site in Spain.
Trial summary
In adulthood, limited mobility and pain are very common and often the first clear sign of functional decline. The loss of independent mobility is related to higher rates of functional disability and mortality; however, it is also susceptible to interventions through exercises. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Functional Insufficiency, Aging
- What is being tested?
- Therapeutic exercise by fitness machines
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2014to Sep 2015
- 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 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ability to complete self-reported questionnaires
- Autonomous ambulation that allows the realization of functional test
- Accept and consent to voluntarily participate in the study
- Preclinical mobility restriction and/or pain in absence of important pathologies.
Who cannot join
- Present contraindications for physical exercise
- Receiving physiotherapy treatment during the time of the trial.
- Modification of physical habits
- Change the pattern or usual pharmacotherapy
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Alazne Ruiz de Escudero Zapico
Zaragoza, Zaragoza, 50009
Alazne Ruiz de Escudero Zapico, 615007759, alazne@unizar.es
About this study
Official title: Effects of a Therapeutic Exercise Program by a Feedback a Motor Control System in the Elderly
In adulthood, limited mobility and pain are very common and often the first clear sign of functional decline. The loss of independent mobility is related to higher rates of functional disability and mortality; however, it is also susceptible to interventions through exercises. With aging, changes in peripheral and central nervous system also occur, which lead to degradation of the sensory receptors as well as a loss of muscle mass and coordination. However, both, structural and functional dysfunctions of the nervous system, can be mitigated by increasing physical activity.
The aim of this study is therefore, to study the effects on pain and functional capacity of a therapeutic exercise training program in an adult people sample. The therapeutic exercise machines proposed in this trial have not been previously analyzed and provide insight into this field due to their design. The design of this new machines allows the adaptation to each concrete clinical situation by the adjustment of different parameters such as feedback, range of movement, time of repetition, intensity, speed and rhythm, which facilitate motor control training.
- Conditions
- Functional Insufficiency, Aging
- Being tested
- Therapeutic exercise by fitness machines
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic exercise by fitness machinesDevice
Therapeutic exercise program by using 8 exercise machine circuit
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Active comparator | Therapeutic exercise Receives: Device: Therapeutic exercise by fitness machines |
| Control Group | No intervention | No treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in pain intensity
Measured by Visual Analogue Scale
Measured: 8 weeks
Change from baseline in range of movement
Measured by a motion capture system
Measured: 8 weeks
Secondary outcomes (3)
Body composition
weight, BMI
Measured: 8 weeks
Functional capacity
spirometry and functional tests of the extremities
Measured: 8 weeks
Quality of life
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2015 (estimated)
- Study startJun 2014
- Primary completionSep 2015 (estimated)
- Study completionSep 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional InsufficiencyStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Zaragoza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alazne Ruiz de Escudero Zapico, Universidad de Zaragoza
- Investigators
- Alazne Ruiz de Escudero Zapico, Principal investigator, Unidad de Investigacion en Fisioterapia. Universida de Zaragoza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02487667
- Sponsor's protocol ID
- A14/001
- Status last verified
- Jun 2015
- First submitted
- 22 Jun 2015
- Last updated
- 1 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Therapeutic Exercise Program by a Feedback a Motor Control System in the Elderly
- ClinicalTrials.gov ID
- NCT02487667
- Acronym / sponsor ID
- A14/001
- Conditions
- Functional Insufficiency, Aging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Universidad de ZaragozaUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Sep 2015 (estimated)
- First posted
- 1 Jul 2015 (estimated)
- 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.
In adulthood, limited mobility and pain are very common and often the first clear sign of functional decline. The loss of independent mobility is related to higher rates of functional disability and mortality; however, it is also susceptible to interventions through exercises. With aging, changes in peripheral and central nervous system also occur, which lead to degradation of the sensory receptors as well as a loss of muscle mass and coordination. However, both, structural and functional dysfunctions of the nervous system, can be mitigated by increasing physical activity.
The aim of this study is therefore, to study the effects on pain and functional capacity of a therapeutic exercise training program in an adult people sample. The therapeutic exercise machines proposed in this trial have not been previously analyzed and provide insight into this field due to their design. The design of this new machines allows the adaptation to each concrete clinical situation by the adjustment of different parameters such as feedback, range of movement, time of repetition, intensity, speed and rhythm, which facilitate motor control training.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Active comparator | Device: Therapeutic exercise by fitness machinesTherapeutic exercise |
| Control Group | No intervention | –No treatment |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ability to complete self-reported questionnaires
- Autonomous ambulation that allows the realization of functional test
- Accept and consent to voluntarily participate in the study
- Preclinical mobility restriction and/or pain in absence of important pathologies.
Key exclusion criteria (4 listed)
- Present contraindications for physical exercise
- Receiving physiotherapy treatment during the time of the trial.
- Modification of physical habits
- Change the pattern or usual pharmacotherapy
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 |
|---|---|---|
| Therapeutic exercise by fitness machinesTherapeutic exercise program by using 8 exercise machine circuit | Device | Intervention Group |
Primary outcome
Change from baseline in pain intensity
Time frame: 8 weeks
Measured by Visual Analogue Scale
Change from baseline in range of movement
Time frame: 8 weeks
Measured by a motion capture system
3 secondary outcomes
Body composition
Time frame: 8 weeks
Functional capacity
Time frame: 8 weeks
Quality of life
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2015.
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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.
Alazne Ruiz de Escudero Zapico principal investigator
Unidad de Investigacion en Fisioterapia. Universida de Zaragoza
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic exercise by fitness machines in people with Functional Insufficiency and Aging, run by Universidad de Zaragoza at 1 site in Spain.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 1 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alazne Ruiz de Escudero Zapico (615007759, alazne@unizar.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in pain intensity (time frame: 8 weeks). The study lists 2 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 1 Jul 2015.