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Physical TherapyNCT03529864

Effects of Therapeutic Exercise on Quality of Life

A study testing Exercise Therapy in people with Physical Therapy and Health Promotion, run by Universidade da Coruña.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
What is being tested?
Exercise Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
57 participants
Where
No sites listed yet
Study dates
3 Oct 2014to Oct 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

About this study

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

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.

Read the 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.

Being tested
Exercise Therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exercise TherapyOther

Study groups in NCT03529864
Study groupRoleWhat they receive
Exercise therapyExperimentalThe 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
Receives: Other: Exercise Therapy
ControlNo 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 7 min

Secondary outcomes (5)

  1. Nordic Musculoskeletal Questionnaire (NMQ-E)

    It collects information regarding the onset, prevalence, and consequences of musculoskeletal pain. It inquires about ''ache, pain or discomfort'' and 9 body regions are visually depicted on a body chart. In total, it is comprised of 11 questions, equating to 99 data items generated by the tool. With the exception of age data, all response options are dichotomous (yes/no). Questions are ordered in such a way that those relating to the respondents' lifetime (''ever'') are asked first, followed by prevalence questions, and lastly items relating to consequences of pain in the previous year. Respondents are asked to answer all questions for a body region before progressing to the next region (horizontally). In 2 instances (specifically, questions relating to lifetime and annual prevalence of trouble), if the respondent answer no, they are directed to go on to the next body region and all remaining questions for that region are automatically coded as negative responses.

    Measured: 4 min

  2. Visual Analogy Scale (VAS)

    The pain VAS is a single-item scale. It is a continuous scale comprised of a horizontal line, 10 centimetres (100 mm) in length, anchored by 2 verbal descriptors, one for each symptom extreme: "no pain" (score of 0) and "worst imaginable pain" (score of 100 [100-mm scale]). Although there are no normative values, the recommended cut-off points were used to interpret the score obtained on this scale: no pain (0-4 mm), slight pain (5-44 mm), moderate pain (45-74 mm) and severe pain (75-100 mm) (Hawker GA et al. 2011).

    Measured: 2 min

  3. Oswestry Disability Index (ODI)

    Lumbar disability

    Measured: 4 min

  4. Neck Disability Index (NDI)

    Neck disability

    Measured: 4 min

  5. Flexor trunk endurance test

    Abdominal muscle endurance

    Measured: 10 min

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2018
  2. Study start3 Oct 2014
  3. Primary completion10 Oct 2014
  4. Study completionOct 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
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.
Enrolment
57 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03529864
Sponsor's protocol ID
Experim Fac
Status last verified
May 2018
First submitted
15 Mar 2018
Last updated
18 May 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 24665116

  • 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.

    PubMed 24482302

  • 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.

    PubMed 26752509

  • 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.

    PubMed 27317503

Questions about this trial

What is this clinical trial studying?

A study testing Exercise Therapy in people with Physical Therapy and Health Promotion, run by Universidade da Coruña.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 May 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

SF-36v2 Health Survey (time frame: 7 min). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03529864, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2018.

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