Remote Exercise Programs and Preventive Training in Asymptomatic Individuals

May 30, 2023 updated by: Yasemin Özel Aslıyüce, Hacettepe University

Investigation of The Effects of Remote Exercise Programs and Preventive Training on Muscle Architecture and Functional Level in Asymptomatic Individuals

In recent years, it has been emphasized that preventive approaches are a less costly and more effective way to treat a pathology. Primary preventive approaches should become widespread, especially in problems with changeable risk factors such as spine health. Various preventive approaches and exercise training seem to be an effective way to prevent the development of back and neck pain. Again, in recent years, the pandemic process has increased the interest and need for tele-rehabilitation. As a result, scientific research results on tele-rehabilitation are needed as a necessity to adapt to the Covid-19 epidemic and the globalizing world. The aim of the thesis study planned in this context is to investigate the effectiveness of remote exercise applications on lumbar and cervical region muscle architecture and functionality in asymptomatic individuals.Another aim of this study is to investigate the remote applicability of functional level, quality of life, kinesophobia and cognitive assessment.

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.
54

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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Sıhhiye
      • Ankara, Sıhhiye, Turkey, 06100
        • Yasemin Özel Aslıyüce

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 55 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Have not experienced back and neck pain for at least 3 months,
  • Between the ages of 18-55,
  • Literate,
  • Individuals who are capable of understanding exercises (Montreal Cognitive Assessment Scale (MOCA) (19) total score> 21) will be included in the study.

Exclusion Criteria:

  • Having been diagnosed with cervical or lumbar region pathologies,
  • Cervical radiculopathy, thoracic outlet syndrome,
  • Malignant condition,
  • Have systemic diseases such as neurological, psychological, cardiovascular, rheumatology and loss of function due to these diseases,
  • Previous surgery history in the spine and upper extremity, including the cervical and lumbar region,
  • Fracture in the spine and upper extremity, including the cervical and lumbar region, with an inflammatory history,
  • Acute infection,
  • Continuing another rehabilitation program,
  • Individuals who do not agree to participate in the study and do not give written consent will be excluded from the study.

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: Treatment
  • 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: Treatment Group
Remotely Exercises 3 times a week, 8 weeks remotely (with video) spinal stabilization exercises
Other: Exercise
Spinal stabilization exercise
Other: Control Group
Face to Face Exercises 3 times a week, 8 weeks face to face (in clinic) spinal stabilization exercises
Other: Exercise
Spinal stabilization exercise
Other: Remotely assessment Group-Face to Face Assessment Group
First, a remote evaluation and then a face to face evaluation will be made.
Other: Remotely and face to face evaluation of Functional Capacity Level
Quality of life assessment (SF-36), and cognitive assessment ((Montreal Cognitive Assessment Scale (MOCA)) will be administered face to face. Functional capacity assessment tests will be administered both face-to-face and remotely. All participants will be administered both remotely and face-to-face. The order of the remote and face-to-face evaluations will be determined by the closed envelope randomization method. The remote evaluation will be done by video interview method under the direction of the researcher. During the remote evaluation, the necessary equipment for the participant will be prepared in the unit in advance. There will be a 10-30 minute rest interval between each evaluation.This application will only be applied at the beginning of the exercise program.After the 8-week program, only face-to-face evaluation will be made.
Other: Face to Face Assessment Group-Remotely assessment Group
First, a facet o face evaluation and then a remote evaluation will be made.
Other: Remotely and face to face evaluation of Functional Capacity Level
Quality of life assessment (SF-36), and cognitive assessment ((Montreal Cognitive Assessment Scale (MOCA)) will be administered face to face. Functional capacity assessment tests will be administered both face-to-face and remotely. All participants will be administered both remotely and face-to-face. The order of the remote and face-to-face evaluations will be determined by the closed envelope randomization method. The remote evaluation will be done by video interview method under the direction of the researcher. During the remote evaluation, the necessary equipment for the participant will be prepared in the unit in advance. There will be a 10-30 minute rest interval between each evaluation.This application will only be applied at the beginning of the exercise program.After the 8-week program, only face-to-face evaluation will be made.

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
Evaluation of Muscle Thickness with Ultrasonography
Time Frame: 15 minutes, through study completion, an average of 8 weeks, Change from Baseline Muscle Thickness at 8 weeks
Ultrasonography is used to evaluate the architectural properties of the muscle (such as thickness) in chronic painful musculoskeletal problems such as neck-back pain. Muscle architecture measurements with ultrasound will be carried out before and after the exercise program by the specialist radiology doctor who is blind to the results of the study using 3.5-10 MHz convex and linear probes (Soundcam Mobile Ultrasound Device). Within the scope of our study, the muscle thickness of the spinal muscles will be evaluated in the resting position.
15 minutes, through study completion, an average of 8 weeks, Change from Baseline Muscle Thickness at 8 weeks
Evaluation of Functional Capacity Level with Functional Capacity Assessment Test
Time Frame: 20 minutes, through study completion, an average of 8 weeks, Change from Baseline Functional Capacity Level at 8 weeks
Functional capacity assessment evaluates the effectiveness (time to completion, weight it can handle) of each activity that includes different activities for neck pain. The test includes the activities of "repetitive reaching out, lifting objects overhead, working overhead". The validity and reliability of the Functional Capacity Assessment Test in individuals with chronic neck pain has been shown. The time individuals can complete the tests will be recorded.
20 minutes, through study completion, an average of 8 weeks, Change from Baseline Functional Capacity Level at 8 weeks
Evaluation of Functional Capacity Level with Back Performance Scale
Time Frame: 10 minutes, through study completion, an average of 8 weeks, Change from Baseline Functional Capacity Level at 8 weeks
The back performance test (Back Performance Scale) is a test that evaluates the effectiveness of each activity that includes 5 different activities (socks test, gathering test, righting test, fingertip-floor test, carrying test). The Back Performance Scale test is scored between 0-15 points. An increase in score indicates a poor result.
10 minutes, through study completion, an average of 8 weeks, Change from Baseline Functional Capacity Level at 8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Evaluation of quality of life
Time Frame: 5 minutes, through study completion, an average of 8 weeks, Change from Baseline quality of life at 8 weeks
Quality of life Assessment: SF-36 SF-36 is a scale consisting of 36 questions that evaluates the health status of the person with 8 sub-items (physical function, role limitations, social function, mental health, vitality, pain, general health). Scoring between 0-100 is made separately for each sub-item. It indicates good health as the score approaches 100. The validity and reliability study, Koçyiğit et al. Made by.
5 minutes, through study completion, an average of 8 weeks, Change from Baseline quality of life at 8 weeks
Evaluation of Exercise Adaptation Assessment: Exercise Adaptation Rating Scale (EUAS)
Time Frame: 5 minutes, through study completion, an average of 8 weeks, Change from Baseline Exercise Adaptation Assessment at 8 weeks
It will be evaluated using the Exercise Adherence Rating Scale (EARS), which evaluates exercise compliance (52). The first 2 parts of the scale consist of 6 questions and the third part consists of 10 questions. The first part is not included in the scoring and the maximum score to be obtained from two parts is 64. An increase in score indicates an increased adaptation to exercise. The Turkish validity and reliability study of the scale was conducted in 2019 by Korkmaz et al.
5 minutes, through study completion, an average of 8 weeks, Change from Baseline Exercise Adaptation Assessment at 8 weeks
Evaluation of Difficulty of Functional Activities and Exercise Program Satisfaction (GAS)
Time Frame: 5 minutes, through study completion, an average of 8 weeks, Change from Baseline Difficulty of Functional Activities and Exercise Program Satisfaction at 8 weeks
VAS is used in measurement by digitizing the values that cannot be measured numerically. It is a line measurement, often on a 10 cm long horizontal or vertical line, where the person indicates his condition. Pain is used in the literature to evaluate satisfaction. In the satisfaction evaluation, it is evaluated as "0: there was no decrease in complaints, I am not satisfied, 10: complaints completely disappeared, I am very satisfied". In the study, the functional activity difficulty will be evaluated as "0: Being unable to do the activity, 10: Being able to do the activity at the level before the neck pain started".
5 minutes, through study completion, an average of 8 weeks, Change from Baseline Difficulty of Functional Activities and Exercise Program Satisfaction at 8 weeks

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.
Hacettepe University

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.
April 14, 2021

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.
February 20, 2023

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.
March 1, 2023

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 8, 2021

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 8, 2021

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 11, 2021

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.
May 31, 2023

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.
May 30, 2023

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.
May 1, 2023

More Information

Terms related to this study

Keywords

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.
  • KA-20110

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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