- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02487667
Therapeutic Exercise Training in the Elderly
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Zaragoza, Spain, 50009
- Recruiting
- Alazne Ruiz de Escudero Zapico
-
Contact:
- Alazne Ruiz de Escudero Zapico
- Phone Number: 615007759
- Email: alazne@unizar.es
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Present contraindications for physical exercise
- Receiving physiotherapy treatment during the time of the trial.
- Modification of physical habits
- Change the pattern or usual pharmacotherapy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Intervention Group
Therapeutic exercise
|
Therapeutic exercise program by using 8 exercise machine circuit
|
|
No Intervention: Control Group
No treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline in pain intensity
Time Frame: 8 weeks
|
Measured by Visual Analogue Scale
|
8 weeks
|
|
Change from baseline in range of movement
Time Frame: 8 weeks
|
Measured by a motion capture system
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of life
Time Frame: 8 weeks
|
8 weeks
|
|
|
Body composition
Time Frame: 8 weeks
|
weight, BMI
|
8 weeks
|
|
Functional capacity
Time Frame: 8 weeks
|
spirometry and functional tests of the extremities
|
8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Alazne Ruiz de Escudero Zapico, Unidad de Investigacion en Fisioterapia. Universida de Zaragoza
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- A14/001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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