Effects of Therapeutic Exercise on Quality of Life

May 7, 2018 updated by: Beatriz Rodríguez-Romero, Universidade da Coruña

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
7 min

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 min
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).
2 min
Oswestry Disability Index (ODI)
Time Frame: 4 min
Lumbar disability
4 min
Neck Disability Index (NDI)
Time Frame: 4 min
Neck disability
4 min
Flexor trunk endurance test
Time Frame: 10 min
Abdominal muscle endurance
10 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade da Coruña

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 3, 2014

Primary Completion (Actual)

October 10, 2014

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

March 15, 2018

First Submitted That Met QC Criteria

May 7, 2018

First Posted (Actual)

May 18, 2018

Study Record Updates

Last Update Posted (Actual)

May 18, 2018

Last Update Submitted That Met QC Criteria

May 7, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • Experim Fac

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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