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OpenTrials
Completed

NCT Number: NCT03529864

Effects of Therapeutic Exercise on Quality of Life

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.

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Key information

Conditions

Physical Therapy Health Promotion Quality of Life

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exercise therapy

Other

Primary outcomes

  1. SF-36v2 Health Survey

    Time frame: 7 min

    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.

Secondary outcomes

  1. Nordic Musculoskeletal Questionnaire (NMQ-E)

    Time frame: 4 min

    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.

  2. Visual Analogy Scale (VAS)

    Time frame: 2 min

    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).

  3. Oswestry Disability Index (ODI)

    Time frame: 4 min

    Lumbar disability

  4. Neck Disability Index (NDI)

    Time frame: 4 min

    Neck disability

  5. Flexor trunk endurance test

    Time frame: 10 min

    Abdominal muscle endurance

Sponsors and collaborators

Lead sponsor

Universidade da Coruña

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2016
First posted
May 18, 2018
Registry last updated
May 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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