Healthy PeopleNCT04704570
Remote Exercise Programs and Preventive Training in Asymptomatic Individuals
A study testing Exercise and Remotely and face to face evaluation of Functional Capacity Level in people with Healthy People, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy People
- What is being tested?
- Exercise and Remotely and face to face evaluation of Functional Capacity Level
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Apr 2021to 1 Mar 2023
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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,
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Healthy People
- Being tested
- Exercise, Remotely and face to face evaluation of Functional Capacity Level
- Keywords
- spinal stabilization exercise, tele-rehabilitation, muscle architecture, functional level
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Spinal stabilization exercise
Remotely and face to face evaluation of Functional Capacity LevelOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Remotely Exercises 3 times a week, 8 weeks remotely (with video) spinal stabilization exercises Receives: Other: Exercise |
| Control Group | Other | Face to Face Exercises 3 times a week, 8 weeks face to face (in clinic) spinal stabilization exercises Receives: Other: Exercise |
| Remotely assessment Group-Face to Face Assessment Group | Other | First, a remote evaluation and then a face to face evaluation will be made. Receives: Other: Remotely and face to face evaluation of Functional Capacity Level |
| Face to Face Assessment Group-Remotely assessment Group | Other | First, a facet o face evaluation and then a remote evaluation will be made. Receives: Other: Remotely and face to face evaluation of Functional Capacity Level |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Muscle Thickness with Ultrasonography
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.
Measured: 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
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.
Measured: 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
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.
Measured: 10 minutes, through study completion, an average of 8 weeks, Change from Baseline Functional Capacity Level at 8 weeks
Secondary outcomes (3)
Evaluation of quality of life
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.
Measured: 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)
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.
Measured: 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)
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".
Measured: 5 minutes, through study completion, an average of 8 weeks, Change from Baseline Difficulty of Functional Activities and Exercise Program Satisfaction at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2021
- Study start14 Apr 2021
- Primary completion20 Feb 2023
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy PeopleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasemin Özel Aslıyüce, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04704570
- Sponsor's protocol ID
- KA-20110
- Status last verified
- May 2023
- First submitted
- 8 Jan 2021
- Last updated
- 31 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of The Effects of Remote Exercise Programs and Preventive Training on Muscle Architecture and Functional Level in Asymptomatic Individuals
- ClinicalTrials.gov ID
- NCT04704570
- Acronym / sponsor ID
- KA-20110
- Conditions
- Healthy People
- Keywords
- spinal stabilization exercise, tele-rehabilitation, muscle architecture, functional level
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 14 Apr 2021 (actual)
- Primary completion
- 20 Feb 2023 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 11 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Other: ExerciseRemotely Exercises 3 times a week, 8 weeks remotely (with video) spinal stabilization exercises |
| Control Group | Other | Other: ExerciseFace to Face Exercises 3 times a week, 8 weeks face to face (in clinic) spinal stabilization exercises |
| Remotely assessment Group-Face to Face Assessment Group | Other | Other: Remotely and face to face evaluation of Functional Capacity LevelFirst, a remote evaluation and then a face to face evaluation will be made. |
| Face to Face Assessment Group-Remotely assessment Group | Other | Other: Remotely and face to face evaluation of Functional Capacity LevelFirst, a facet o face evaluation and then a remote evaluation will be made. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseSpinal stabilization exercise | Other | Control Group, Treatment Group |
| Remotely and face to face evaluation of Functional Capacity LevelQuality 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, Remotely assessment Group-Face to Face Assessment Group |
Primary outcome
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.
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.
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.
3 secondary outcomes
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Remotely and face to face evaluation of Functional Capacity Level in people with Healthy People, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 4 inclusion and 9 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 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 May 2023.