NCT02487667

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 22, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 1, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

July 1, 2015

Status Verified

June 1, 2015

Enrollment Period

1.3 years

First QC Date

June 22, 2015

Last Update Submit

June 29, 2015

Conditions

Outcome Measures

Primary Outcomes (2)

  • Change from baseline in pain intensity

    Measured by Visual Analogue Scale

    8 weeks

  • Change from baseline in range of movement

    Measured by a motion capture system

    8 weeks

Secondary Outcomes (3)

  • Body composition

    8 weeks

  • Functional capacity

    8 weeks

  • Quality of life

    8 weeks

Study Arms (2)

Intervention Group

ACTIVE COMPARATOR

Therapeutic exercise

Device: Therapeutic exercise by fitness machines

Control Group

NO INTERVENTION

No treatment

Interventions

Therapeutic exercise program by using 8 exercise machine circuit

Intervention Group

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Present contraindications for physical exercise
  • Receiving physiotherapy treatment during the time of the trial.
  • Modification of physical habits
  • Change the pattern or usual pharmacotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alazne Ruiz de Escudero Zapico

Zaragoza, Zaragoza, 50009, Spain

RECRUITING

Study Officials

  • Alazne Ruiz de Escudero Zapico

    Unidad de Investigacion en Fisioterapia. Universida de Zaragoza

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alazne Ruiz de Escudero Zapico

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physical Therapist

Study Record Dates

First Submitted

June 22, 2015

First Posted

July 1, 2015

Study Start

June 1, 2014

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

July 1, 2015

Record last verified: 2015-06

Locations