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ExerciseNCT03825614

The Effect of Exercises on Young Adults

A study testing training in people with Exercise and Young Adults, run by University of Yalova.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 25 yearsHealthy volunteers can take part
Conditions the study is for
Exercise, Young Adults, Quality of Life
What is being tested?
training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
125 participants
Where
No sites listed yet
Study dates
Jan 2016to Feb 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 25 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • They were apparently healthy and had no systematic diseases or any problem preventing their participation in any exercise program.

Who cannot join

  • 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.

About this study

Official title: 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.

Being tested
training
Medical subject headings
Motor Activity, Pain, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • trainingBehavioural

    plates and therapeutic exercises applied on young adults

Study groups in NCT03825614
Study groupRoleWhat they receive
training gruopExperimentalThe 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.
Receives: Behavioral: training
training groupActive comparatorTherapeutic 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.
Receives: Behavioral: training
Control groupNo interventionParticipants in the control group have no exercise in this study.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assessment of changes in the pain

    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.

    Measured: 12 weeks

  2. Assessment of changes in the depression

    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).

    Measured: 12 weeks

  3. Health related quality of life

    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).

    Measured: 12 weeks

  4. Functional level

    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).

    Measured: 12 weeks

  5. Assessment of changes in the Waist and Hip circumference

    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).

    Measured: 12weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jan 2019
  2. Study startJan 2016
  3. Primary completionJan 2017
  4. Study completionFeb 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
randomized controlled
Masking
Single blind
Who is masked
Investigator
Enrolment
125 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03825614
Sponsor's protocol ID
UYalova
Status last verified
Jan 2019
First submitted
4 Jan 2019
Last updated
31 Jan 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 28425239

  • 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.

    PubMed 19329051

  • 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.

    PubMed 22104298

Questions about this trial

What is this clinical trial studying?

A study testing training in people with Exercise and Young Adults, run by University of Yalova.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assessment of changes in the pain (time frame: 12 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03825614, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2019.

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