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Clinical Trials/NCT03529864
NCT03529864
Completed
N/A

Effects of Therapeutic Exercise on Health-related Quality of Life and Disability in Students: a Randomized Controlled Trial

Universidade da Coruña0 sites57 target enrollmentOctober 3, 2014

Overview

Phase
N/A
Intervention
Not specified
Conditions
Physical Therapy
Sponsor
Universidade da Coruña
Enrollment
57
Primary Endpoint
SF-36v2 Health Survey
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

The main objective was to determine the efficacy and safety of a therapeutic exercise program for students. Secondary objectives, determine the prevalence and intensity of musculoskeletal pain (MSP), disability, Health-Related Quality of Life (HRQOL), and satisfaction and perceived improvement with program.

Detailed Description

Methodology: randomized, controlled, open clinical trial. Subjects were recruited from students of Degree of Physiotherapy. Inclusion and exclusion criteria were established. Physical Component Summary (PCS) of SF36, as primary outcomes, was taken to the sample size. Randomization was single-blind. Secondary response variables were measured through the Nordic Musculoskeletal Questionnaire, Visual Analogue Scale, Oswestry Disability Index, Neck Disability Index, trunk flexor endurance test and finger-floor distance test. An assessment pre and post intervention was performed. This consisted of a therapeutic exercise program based on the stabilization, 9 sessions of 1 hour. For statistical analysis, the Shapiro-Wilk test, Student's t test or test MannWitney, the statistic (X2) chi-square or Fisher's exact test were applied. The level of significance was taken as p \<0.05. Information sheet and informed consent model was delivered.

Registry
clinicaltrials.gov
Start Date
October 3, 2014
End Date
October 2016
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Beatriz Rodríguez-Romero

University Lecturer in the Department of Biomedical Sciences, Medicine and Physiotherapy. University of A Coruña

Universidade da Coruña

Eligibility Criteria

Inclusion Criteria

  • students taking a course of the Physiotherapy Degree
  • having enrolled in October 2014
  • having given their informed consent.

Exclusion Criteria

  • not accepting to take part in the study,
  • not attending the initial evaluation sessions,
  • having any type of cardiovascular, neuromusculoskeletal or systemic diseases that restricted exercise participation.

Outcomes

Primary Outcomes

SF-36v2 Health Survey

Time Frame: 7 min

This is self-administered and consists of 36 items that assess the state of health in 8 dimensions: physical function (PF), role-physical (RP), bodily pain (BP), general health (GH), vitality (VT), social function (SF), role-emotional (RE) and mental health (MH). These dimensions may be reduced to 2 scores: Physical Component Summary (PCS) and Mental Component Summary (MCS). In order to interpret the results, standardized scores are obtained with the values for the reference population standards, whereby a score of 50 (SD = 10) represented the mean for the general population, and a score of 10 was one standard deviation. Values over or below 50 have to be respectively interpreted as better or worse than those of the reference population.

Secondary Outcomes

  • Visual Analogy Scale (VAS)(2 min)
  • Oswestry Disability Index (ODI)(4 min)
  • Neck Disability Index (NDI)(4 min)
  • Flexor trunk endurance test(10 min)
  • Nordic Musculoskeletal Questionnaire (NMQ-E)(4 min)

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