Remote Exercise Programs and Preventive Training in Asymptomatic Individuals

NCT04704570 | Completed DMC

• 1 other identifier: KA-20110
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy People

Keywords

spinal stabilization exercise; tele-rehabilitation; muscle architecture; functional level

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  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

  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)

  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)

  5 minutes, through study completion, an average of 8 weeks, Change from Baseline Difficulty of Functional Activities and Exercise Program Satisfaction at 8 weeks

Study Arms (4)

Treatment Group

EXPERIMENTAL

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

Other: Exercise

Control Group

OTHER

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

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.

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.

Other: Remotely and face to face evaluation of Functional Capacity Level

Interventions

Exercise OTHER

Spinal stabilization exercise

Control Group; Treatment Group

Remotely and face to face evaluation of Functional Capacity Level OTHER

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.

Face to Face Assessment Group-Remotely assessment Group; Remotely assessment Group-Face to Face Assessment Group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Yasemin Özel Aslıyüce

Ankara, Sıhhiye, 06100, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant, Physiotherapist

Study Record Dates

• First Submitted: January 8, 2021
• First Posted: January 11, 2021
• Study Start: April 14, 2021
• Primary Completion: February 20, 2023
• Study Completion: March 1, 2023
• Last Updated: May 31, 2023

Record last verified: 2023-05

Locations

TU (1)