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CompletedNCT04704570Updated May 31, 2023

Remote Exercise Programs and Preventive Training in Asymptomatic Individuals

An interventional study of Exercise and Remotely and face to face evaluation of Functional Capacity Level in Healthy People, sponsored by Hacettepe University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-31.

Sponsored by Hacettepe University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
54
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Healthy People

Keywords

  • spinal stabilization exercise
  • tele-rehabilitation
  • muscle architecture
  • functional level
03

In context

Lead sponsor

Hacettepe University is the lead sponsor of 1,003 studies on the registry; 215 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
54 participants (actual)

Study arms

  • Experimental
    Treatment Group

    Remotely Exercises 3 times a week, 8 weeks remotely (with video) spinal stabilization exercises

    Other: Exercise

  • Other
    Control Group

    Face to Face Exercises 3 times a week, 8 weeks face to face (in clinic) spinal stabilization exercises

    Other: 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

  • 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

Interventions

  • OtherExercise

    Spinal stabilization exercise

  • OtherRemotely 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 15 minutes, through study completion, an average of 8 weeks, Change from Baseline Muscle Thickness at 8 weeks

  2. 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.

    Time frame: 20 minutes, through study completion, an average of 8 weeks, Change from Baseline Functional Capacity Level at 8 weeks

  3. 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.

    Time frame: 10 minutes, through study completion, an average of 8 weeks, Change from Baseline Functional Capacity Level at 8 weeks

Secondary outcomes

  1. 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.

    Time frame: 5 minutes, through study completion, an average of 8 weeks, Change from Baseline quality of life at 8 weeks

  2. 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.

    Time frame: 5 minutes, through study completion, an average of 8 weeks, Change from Baseline Exercise Adaptation Assessment at 8 weeks

  3. 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".

    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

07

Study locations

1 site
  • Yasemin Özel Aslıyüce
    Ankara, Sıhhiye 06100, Turkey (Türkiye)
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 31, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04704570
Responsible party
Yasemin Özel Aslıyüce (Research Assistant, Physiotherapist, Hacettepe University) — Principal investigator
First posted
Jan 11, 2021
Start date
Apr 14, 2021
Primary completion
Feb 20, 2023
Completion
Mar 1, 2023
Last update
May 31, 2023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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