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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
125

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: training
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.
Behavioral: training
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Yalova

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 4, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 30, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 31, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 31, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 30, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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