- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03825614
The Effect of Exercises on Young Adults
January 30, 2019 updated by: asuman saltan, University of Yalova
Does The Pilates or Therapeutic Exercises Effects on Functional Level, Depression, Pain, Qualıty of Life in Young Adults
The aim of this study was to assess the treatment effect of plates and conventional exercises on health related quality of life, pain, functional level, psychological state in young adults.
Randomised controlled study.
Participants were randomly divided into 3 groups: a plates exercise group (n = 29), a therapeutic exercise group (n = 21), and a control group (n = 35).
The therapeutic and plates groups underwent related training programs for 3 month, while the controls had no specific training.
After demographic knowledge were collected the investigators carried out the following assessments on all participants: the Visual Analog Scale (VAS), Waist/ Hip ratio (WHr), Beck Depression Inventory (BDI), Oswestry Disability Index (ODI), Notthingham Health Profile (NHP).
All subjects were evaluated at baseline and post-training.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
125
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
18 years to 25 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
• They were apparently healthy and had no systematic diseases or any problem preventing their participation in any exercise program.
Exclusion Criteria:
- Having a systemic pathology, including inflammatory, rheumatologic, or metabolic diseases
- Having any musculoskeletal injury, pathology, or structural deformity related to the spine or extremities
- Having any active intervention including corticosteroid or any medication in the previous 3 months.
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
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: training gruop
The plates exercise program is concerned with the following main principles: efficient breathing, mental concentration, relaxation, correct spine elongation and posture, correct abdominal muscle control over spine stability and mobility, correct function of each upper and lower limb, precision, lowing integrated movement, and achieving muscle strength and stamina.
|
plates and therapeutic exercises applied on young adults
|
|
Active Comparator: training group
Therapeutic exercise program was designed according to the American Collage of Sports Medicine's recommendations for healthy people.
The exercise program was conducted using low- to moderate-intensity therapeutic exercises.
These therapeutic exercises included a short educational talk that provided information on proper body mechanics, the benefits of exercise, realistic goal-setting, and overcoming common barriers (such as fear) when developing an exercise routine.
|
plates and therapeutic exercises applied on young adults
|
|
No Intervention: Control group
Participants in the control group have no exercise in this study.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assessment of changes in the pain
Time Frame: 12 weeks
|
A visual analogue scale (VAS) was used to their level of pain subjects experienced throughout these activities.
The VAS is comprised of a 10 cm horizontal line, wherein 0 indicates "no pain" and 10 indicates "unbearable pain" (Sang, Sang, Dong and Byung, 2016).
Participants were asked to mark the strength of their ongoing musculoskeletal pain on the horizontal line.
|
12 weeks
|
|
Assessment of changes in the depression
Time Frame: 12 weeks
|
The Back Depression Inventory (BDI) was used to determine patients' level of depression; each item on the scale is given a score of one to three, allowing for a maximum test score of 63 according to form.
A subjects' total overall score is then used as an indicator of the presence and severity of depression: a total score lower than 10 indicates no depression, a score of 10-17 indicates mild depression, a score of 18-29 indicates moderate-to-severe depression, and a score of 30 or above indicates severe depression (Muyan, Sancak and Demir, 2017).
|
12 weeks
|
|
Health related quality of life
Time Frame: 12 weeks
|
The Turkish version of the Nottingham Health Profile (NHP) was used to assess participants' health-related quality of life.
The NHP is a general quality of life questionnaire that measures individuals' perceived health problems and the extent to which these problems affect their normal daily activities.
The questionnaire is comprised of 38 items and evaluates six dimensions of healthy individuals' health statuses, these include: energy (three items), pain (eight items), emotional reactions (nine items), sleep (five items), social isolation (five items) and physical activity (eight items).
The test includes a list of yes/no questions.
Each section yields a score between 0 and 100 for each subject, where 0 represents the best possible health status and 100 represent the worst possible health status (Liang, Wang and Tao, 2015).
|
12 weeks
|
|
Functional level
Time Frame: 12 weeks
|
The Oswestry Disability Index (ODI) questionnaires were distributed to participants and scored according to the study by Yakut et al.
The research authors noted that some of the questions on the ODI are directly related to physical activities (lifting, walking, etc.).
The level of disability was evaluated using the ODI, which is a condition specific questionnaire regarding how low back pain affects activities of daily living.
The questionnaire rates 10 different activities based on a six-point scale, with 0 for ''no pain at all'' and 5 for ''cannot perform due to pain''.
The higher the score, the greater the disability the subject was deemed to have (Rodríguez-Romero, Bello, Vivas Costa and Carballo-Costa, 2018).
|
12 weeks
|
|
Assessment of changes in the Waist and Hip circumference
Time Frame: 12weeks
|
To find the waist/hip (WHr) ratio, participants' waist circumference was taken in centimeters (cm) using a tape measure to measure the point midway between the costal margin and iliac crest on the mid-axillary line, with the subject standing and breathing normally.
Hip circumference (cm) was measured at the widest point around the greater trochanter.
The waist-to-hip ratios of participants were calculated by dividing their waist measurement by their hip measurement (Tam and Çakır, 2012).
|
12weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: saltan, Researcher
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
- Toprak Celenay S, Ozer Kaya D. An 8-week thoracic spine stabilization exercise program improves postural back pain, spine alignment, postural sway, and core endurance in university students:a randomized controlled study. Turk J Med Sci. 2017 Apr 18;47(2):504-513. doi: 10.3906/sag-1511-155.
- Caldwell K, Harrison M, Adams M, Triplett NT. Effect of Pilates and taiji quan training on self-efficacy, sleep quality, mood, and physical performance of college students. J Bodyw Mov Ther. 2009 Apr;13(2):155-63. doi: 10.1016/j.jbmt.2007.12.001. Epub 2008 Feb 20.
- Ozer Kaya D, Duzgun I, Baltaci G, Karacan S, Colakoglu F. Effects of calisthenics and Pilates exercises on coordination and proprioception in adult women: a randomized controlled trial. J Sport Rehabil. 2012 Aug;21(3):235-43. doi: 10.1123/jsr.21.3.235. Epub 2011 Nov 16.
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)
January 1, 2016
Primary Completion (Actual)
January 1, 2017
Study Completion (Actual)
February 1, 2017
Study Registration Dates
First Submitted
January 4, 2019
First Submitted That Met QC Criteria
January 30, 2019
First Posted (Actual)
January 31, 2019
Study Record Updates
Last Update Posted (Actual)
January 31, 2019
Last Update Submitted That Met QC Criteria
January 30, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UYalova
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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