NCT03529864

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2014

Typical duration for not_applicable

Status
completed

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

October 3, 2014

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2014

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

March 15, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 18, 2018

Completed
Last Updated

May 18, 2018

Status Verified

May 1, 2018

Enrollment Period

7 days

First QC Date

March 15, 2018

Last Update Submit

May 7, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • SF-36v2 Health Survey

    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.

    7 min

Secondary Outcomes (5)

  • Nordic Musculoskeletal Questionnaire (NMQ-E)

    4 min

  • Visual Analogy Scale (VAS)

    2 min

  • Oswestry Disability Index (ODI)

    4 min

  • Neck Disability Index (NDI)

    4 min

  • Flexor trunk endurance test

    10 min

Study Arms (2)

Exercise therapy

EXPERIMENTAL

The participants took part in a progressive exercise therapy program for 9 consecutive weeks, once a week. This consisted of group sessions with 8 or 9 students, with each session lasting 60 minutes, supervised by the principal researcher

Other: Exercise Therapy

Control

NO INTERVENTION

The CG did not receive any type of information or instructions apart from the general information sheet on the progress of the study, attached to the informed consent form

Interventions

Exercise therapy

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Hoy D, March L, Brooks P, Blyth F, Woolf A, Bain C, Williams G, Smith E, Vos T, Barendregt J, Murray C, Burstein R, Buchbinder R. The global burden of low back pain: estimates from the Global Burden of Disease 2010 study. Ann Rheum Dis. 2014 Jun;73(6):968-74. doi: 10.1136/annrheumdis-2013-204428. Epub 2014 Mar 24.

    PMID: 24665116BACKGROUND
  • Hoy D, March L, Woolf A, Blyth F, Brooks P, Smith E, Vos T, Barendregt J, Blore J, Murray C, Burstein R, Buchbinder R. The global burden of neck pain: estimates from the global burden of disease 2010 study. Ann Rheum Dis. 2014 Jul;73(7):1309-15. doi: 10.1136/annrheumdis-2013-204431. Epub 2014 Jan 30.

    PMID: 24482302BACKGROUND
  • Steffens D, Maher CG, Pereira LS, Stevens ML, Oliveira VC, Chapple M, Teixeira-Salmela LF, Hancock MJ. Prevention of Low Back Pain: A Systematic Review and Meta-analysis. JAMA Intern Med. 2016 Feb;176(2):199-208. doi: 10.1001/jamainternmed.2015.7431.

    PMID: 26752509BACKGROUND
  • Gross AR, Paquin JP, Dupont G, Blanchette S, Lalonde P, Cristie T, Graham N, Kay TM, Burnie SJ, Gelley G, Goldsmith CH, Forget M, Santaguida PL, Yee AJ, Radisic GG, Hoving JL, Bronfort G; Cervical Overview Group. Exercises for mechanical neck disorders: A Cochrane review update. Man Ther. 2016 Aug;24:25-45. doi: 10.1016/j.math.2016.04.005. Epub 2016 Apr 20.

    PMID: 27317503BACKGROUND

MeSH Terms

Interventions

Exercise Therapy

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking Details
This study was single-blind, parallel-group, and participants were randomly assigned to either the experimental (EG) or the control group (CG). Randomization was designed after initially evaluating the participants. The EG participated in the progressive exercise therapy program. In contrast, the CG did not receive any type of information or instructions apart from the general information sheet on the progress of the study, attached to the informed consent form.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Why: The design of the intervention took into account the available evidence for the prevention and treatment of neck and low back pain. What: Materials: mats, fit-balls, TheraBands, towels, Dyn-Air cushions, chairs, stretchers. Procedures: 3 levels of exercises of increasing difficulty. Standing warm-up exercises. Exercises involving: body scanner and breathing pattern re-education (4 minutes), neutral lumbar-pelvic position control in all directions (6 minutes); transverse abdominis activation (4 minutes); neutral cervical position control (2 minutes); global stabilizer activation exercises for the lumbar-pelvic and cervical-scapular regions (4 minutes); low back flexibility (2 minutes); and muscular strengthening and stretching (12 minutes). Who provided: Physiotherapist. How: Face to face, group with 8-9 participants.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
University Lecturer in the Department of Biomedical Sciences, Medicine and Physiotherapy. University of A Coruña

Study Record Dates

First Submitted

March 15, 2018

First Posted

May 18, 2018

Study Start

October 3, 2014

Primary Completion

October 10, 2014

Study Completion

October 1, 2016

Last Updated

May 18, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share