CClinicalTrials.gg
CompletedNCT03529864Updated May 18, 2018

Effects of Therapeutic Exercise on Quality of Life

An interventional study of Exercise Therapy in Physical Therapy, Health Promotion and Quality of Life, sponsored by Universidade da Coruña. Completed. Per ClinicalTrials.gov, last updated 2018-05-18.

Sponsored by Universidade da Coruña · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 3 years 5 months after the study started (first participant enrolled Oct 2014, registered Mar 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
57
Allocation
Randomized
Sex
All
01

Study 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 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.

02

Conditions studied

  • Physical Therapy
  • Health Promotion
  • Quality of Life
03

In context

Lead sponsor

Universidade da Coruña is the lead sponsor of 33 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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.
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Enrollment
57 participants (actual)

Study arms

  • Experimental
    Exercise therapy

    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

  • No intervention
    Control

    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

  • OtherExercise Therapy
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What researchers measure

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.

    Time frame: 7 min

Secondary outcomes

  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.

    Time frame: 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).

    Time frame: 2 min

  3. Oswestry Disability Index (ODI)

    Lumbar disability

    Time frame: 4 min

  4. Neck Disability Index (NDI)

    Neck disability

    Time frame: 4 min

  5. Flexor trunk endurance test

    Abdominal muscle endurance

    Time frame: 10 min

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Study locations

No study locations are listed for this record.

08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 18, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03529864
Lead sponsor
Universidade da Coruña
Responsible party
Beatriz Rodríguez-Romero (University Lecturer in the Department of Biomedical Sciences, Medicine and Physiotherapy. University of A Coruña, Universidade da Coruña) — Principal investigator
First posted
May 18, 2018
Start date
Oct 3, 2014
Primary completion
Oct 10, 2014
Completion
Oct 2016
Last update
May 18, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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