Effects of Therapeutic Exercise on Quality of Life
1 other identifier
interventional
57
0 countries
N/A
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2014
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 3, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 10, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedFirst Submitted
Initial submission to the registry
March 15, 2018
CompletedFirst Posted
Study publicly available on registry
May 18, 2018
CompletedMay 18, 2018
May 1, 2018
7 days
March 15, 2018
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
EXPERIMENTALThe 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
Control
NO INTERVENTIONThe 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
Eligibility Criteria
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: 24665116BACKGROUNDHoy 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: 24482302BACKGROUNDSteffens 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: 26752509BACKGROUNDGross 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
Intervention Hierarchy (Ancestors)
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
- 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