Clinical trial NCT03529864: Effects of Therapeutic Exercise on Quality of Life
Official title: Effects of Therapeutic Exercise on Health-related Quality of Life and Disability in Students: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Therapy
Health Promotion
Quality of Life
Lead sponsor: Universidade da Coruña
Sponsor class: OTHER
First posted: 2018-05-18
Enrollment: 57
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: SF-36v2 Health Survey
timeFrame: 7 min
Secondary outcomes:
measure: Nordic Musculoskeletal Questionnaire (NMQ-E)
timeFrame: 4 min
measure: Visual Analogy Scale (VAS)
timeFrame: 2 min
measure: Oswestry Disability Index (ODI)
timeFrame: 4 min
measure: Neck Disability Index (NDI)
timeFrame: 4 min
measure: Flexor trunk endurance test
timeFrame: 10 min
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.