NCT03825614

Brief 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. 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

January 4, 2019

Completed
27 days until next milestone

First Posted

Study publicly available on registry

January 31, 2019

Completed
Last Updated

January 31, 2019

Status Verified

January 1, 2019

Enrollment Period

1 year

First QC Date

January 4, 2019

Last Update Submit

January 30, 2019

Conditions

Outcome Measures

Primary Outcomes (5)

  • 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.

    12 weeks

  • 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).

    12 weeks

  • 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).

    12 weeks

  • 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).

    12 weeks

  • 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).

    12weeks

Study Arms (3)

training gruop

EXPERIMENTAL

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.

Behavioral: training

training group

ACTIVE COMPARATOR

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.

Behavioral: training

Control group

NO INTERVENTION

Participants in the control group have no exercise in this study.

Interventions

trainingBEHAVIORAL

plates and therapeutic exercises applied on young adults

training grouptraining gruop

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

MeSH Terms

Conditions

Motor ActivityPainDepression

Condition Hierarchy (Ancestors)

BehaviorNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral Symptoms

Study Officials

  • saltan

    researcher

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: randomized controlled
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ASSIST PROF

Study Record Dates

First Submitted

January 4, 2019

First Posted

January 31, 2019

Study Start

January 1, 2016

Primary Completion

January 1, 2017

Study Completion

February 1, 2017

Last Updated

January 31, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share