Effects of Different Exercise Protocols on Physical and Cognitive Changes in People With Chronic Neck Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-65
SponsorHacettepe University
About this trial
This study aims to investigate the effects of different exercise approaches on physical status, cognitive functions, brain structures, and blood biomarkers in individuals with chronic neck pain.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants aged 20-65
Having neck pain at least 3 months and rated as 3 or more according to the Numeric Rating Scale
Having a score of 10 or more according to the Neck Disability Index
Having a score of 24 or above according to the Mini Mental State Examination
Disqualifiers
Having neuropsychiatric, neurologic, metabolic, cardiovascular, and inflammatory disease(s)
Participating in a rehabilitation program for neck pain in the last 6 months
Having an exercise or sports history of 6 months or more
Presence of brain parenchymal lesion on MRI
Trial design
Design model
Parallel
Treatments tested in this trial
Aerobic exercise
Other interventionParticipants will receive a total of 36 sessions of treatment, 3 sessions per week for 12 weeks. Aerobic exercise training will be performed with a bicycle ergometer, and a 5-minute warm-up (pedaling without resistance) program will be applied before the exercise training, finished by a 5-minute cool-down program (pedaling without resistance). Details of the intervention is described below: 60% of maximum heart rate, for 30 minutes (1-2nd weeks), 60% of maximum heart rate, for 45 minutes (3-4th weeks), 60% of maximum heart rate, for 60 minutes (5-6th weeks), mid-examination (at the end of the 6th week), 75% of maximum heart rate, for 30 minutes (7-8th weeks), 75% of maximum heart rate, for 45 minutes (9-10th weeks), 75% of maximum heart rate, for 60 minutes (11-12th weeks)
Strengthening exercise
Other interventionA 5-minute warm-up (neck and upper extremity range of motion exercises) will be applied before the exercise training, and finished by a 5-minute cool-down program (neck and upper extremity range of motion exercises). Details of the intervention is described below: Isometric neck exercise (MVC 80%,2x10) and Theraband resistive neck and upper body exercises 10 RM-2x10 (1-2nd weeks), Isometric neck exercise (MVC 80%,3x10) and Theraband resistive neck and upper body exercises 10 RM-3x10 (3-4th weeks), Isometric neck exercise (MVC 80%,3x15) and Theraband resistive neck and upper body exercises 10 RM-3x15 (5-6th weeks) , mid-examination (6th week), Isometric neck exercise (MVC 80%,2x10) Theraband resistive neck and upper body exercises 10 RM-2x10 (7-8th weeks), Isometric neck exercise (MVC 80%,3x10) Theraband resistive neck and upper body exercises 10 RM-3x10 (9-10th weeks), Isometric neck exercise (MVC 80%,3x15) Theraband resistive neck and upper body exercises 10 RM-3x15 (11-12th weeks)
Posture and strentching exercise
Other interventionPosture and stretching exercises and stretching exercises will be applied as a control treatment to volunteers with chronic neck pain included in the control group, and at the end of the study, these people will be included in the training program according to the exercise approach that is effective.
Treatment groups
21 Participants
are divided into 3 treatment groupsGroup A: Aerobic exercise groupExperimental treatment 1 intervention
Group B: Strengthening exercise groupExperimental treatment 1 intervention
Group C: Posture and stretching exercise groupOther 1 intervention
Trial outcomes
Primary outcomes
1
Pain Intensity
Numerical scales are among the frequently used one-dimensional pain intensity scales because they are easy to use and effective. In the application, volunteers are asked to choose the number that best describes their pain intensity. Zero indicates no pain, while 10 represents the worst pain imaginable.
Time frame
Baseline, 6th week, and 12th weekOther outcomes
1
Global Cognition
Montreal Cognitive Assessment Test was developed as a rapid screening test for mild cognitive impairments. The Turkish validity and reliability study was conducted. Montreal Cognitive Assessment Test evaluates different cognitive performance areas including short-term memory, visuospatial abilities, executive functions, attention, concentration, working memory, language, orientation to time and place. The highest total score that can be obtained from the test is 30 points.
Time frame
Baseline and 12th week2
Biochemical Measurements
Blood samples will be taken from the participants before and after the exercise treatment in order to observe the changes in blood biomarkers and to reveal the relationship between the masurements and serum levels of the biomarkers. Cortisol, Interleukin 1 Beta, Tumor Necrosis Factor Alpha, Insulin-Like Growth Factor-1, Interleukin-10, Irisin, Brain-Derived Neurotrophic Factor, Nerve Growth Factor and Cathepsin B will be measured in the blood samples taken before and after the exercise treatment. The blood samples taken will be stored at -80°C in a centrifuged manner until they are analyzed. 8 milliliters of blood will be taken from the participants. The serum will be studied and all parameters will be evaluated with the ELISA kit.
Time frame
Baseline and 12th week3
Neuromaging
Brain structural and perfusion weighted imaging magnetic resonance images will be taken to observe changes in brain structure and functions before and after exercise treatment of participants to reveal the relationship between the measurements and brain changes. Structural images will consist of imaging in different sequences and planes (sagittal T1A, isovolumetric axial T1A, axial and coronal T2A, FLAIR (Fluid Attenuated Inversion Recovery), diffusion-weighted imaging, SWI (Susceptibility Weighted Imaging). The obtained radiological images will be analyzed in the FreeSurfer image processing program. After the images are processed with the FreeSurfer software, quantitative vertex-based processing will be used to obtain data such as cortical thickness, gray matter volume and cerebral blood flow in a highly sensitive manner. For each region of interest (ROI) in the Desikan-Killiany atlas, volume, cortical thickness, mean arterial time and cerebral blood flow data will be calculated.
Time frame
Baseline and 12th week4
Cognitive Functions
Trail Making Test: It is used to evaluate selective and sustained attention, visual scanning, information processing speed, and executive functions. The Turkish standardization study of the test was conducted. The test has two parts, A and B. Part A of the test consists of randomly arranging the numbers in circles, and the participant is asked to combine the numbers in order and without lifting the pen. In part B, both the numbers and the letters are randomly arranged in circles. There is a simplified sample exercise section for each section. The participants is asked to combine the numbers and letters without lifting the pen and by paying attention to the order, so that one number becomes one letter. The time it takes the volunteer to complete each section will be recorded.
Time frame
Baseline and 12th weekSponsors and contacts
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Source ClinicalTrials.gov