Therapeutic Exercise Training in the Elderly

Aging Clinical Trial

Official title:

Effects of a Therapeutic Exercise Program by a Feedback a Motor Control System in the Elderly

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02487667
• Other study ID #: A14/001
• Status: Recruiting
• Phase: N/A
• First received: June 22, 2015
• Last updated: June 29, 2015
• Start date: June 2014
• Est. completion date: September 2015

Study information

• Verified date: June 2015
• Source: Universidad de Zaragoza
• Contact: Alazne Ruiz de Escudero Zapico
• Phone: 615007759
• Email: alazne[@]unizar.es
• Is FDA regulated: No
• Health authority: Spain: Ministerio de Sanidad, Servicios Sociales e Igualdad
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 80 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aging
• Functional Insufficiency

Intervention

Device:
• Therapeutic exercise by fitness machines
Therapeutic exercise program by using 8 exercise machine circuit

Locations

Country	Name	City	State
Spain	Alazne Ruiz de Escudero Zapico	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Zaragoza

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in pain intensity	Measured by Visual Analogue Scale	8 weeks	Yes
Primary	Change from baseline in range of movement	Measured by a motion capture system	8 weeks	Yes
Secondary	Body composition	weight, BMI	8 weeks	Yes
Secondary	Functional capacity	spirometry and functional tests of the extremities	8 weeks	Yes
Secondary	Quality of life		8 weeks	Yes