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Effects of Therapeutic Exercise on Quality of Life

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03529864
Enrollment
57
Registered
2018-05-18
Start date
2014-10-03
Completion date
2016-10-31
Last updated
2018-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Promotion, Physical Therapy, Quality of Life

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.

Interventions

OTHERExercise Therapy

Sponsors

Universidade da Coruña
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Masking description

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.

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.

Eligibility

Sex/Gender
ALL
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

* 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.

Design outcomes

Primary

MeasureTime frameDescription
SF-36v2 Health Survey7 minThis 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

MeasureTime frameDescription
Nordic Musculoskeletal Questionnaire (NMQ-E)4 minIt 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.
Visual Analogy Scale (VAS)2 minThe 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).
Oswestry Disability Index (ODI)4 minLumbar disability
Neck Disability Index (NDI)4 minNeck disability
Flexor trunk endurance test10 minAbdominal muscle endurance

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026