Effects of Different Exercise Protocols on Physical and Cognitive Changes in People With Chronic Neck Pain

Official title

Effects of Different Exercise Protocols on Physical Status, Cognitive Functions, Brain Structure, and Blood Biomarkers in People With Chronic Neck Pain

Overview

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.

Detailed description

Chronic neck pain is a common musculoskeletal disorder. It has been stated in the literature that in addition to physical disabilities, cognitive problems may also be observed in these individuals. Still, the neurophysiological and biochemical mechanisms related to these disabilities are not yet sufficiently clear. Previous studies conducted on individuals with chronic neck pain are mostly evaluation studies aimed at existing disabilities, and our planned study seeks to achieve positive improvements in these disabilities by applying a treatment approach known to be effective on physical and cognitive health, such as exercise. Within the scope of the project, neuropsychological tests will be applied to the participants to evaluate attention, memory, visual and spatial structuring, language skills, and executive functions. Participants' brain structural changes will be evaluated with T1-weighted imaging, and brain perfusion changes will be evaluated with Arterial Spin Labeling imaging. Within the scope of physical condition and pain-related evaluations, participants' pain intensity, neck disability levels, muscle strength, functional capacities, pain catastrophizing level, kinesiophobia, central sensitization, and sleep quality will be evaluated. Finally, blood samples of the participants will be collected and serum concentrations of 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 examined. All these assessments will be applied both before and after the exercise applications, and only muscle strength and functional capacities will be measured again at the end of the 6th week so that the exercise program can progress according to the gains in physical condition. Individuals whose initial assessments are completed will be assigned to aerobic exercise, strength exercises, or home exercise control group by stratified randomization method. Exercise applications will be applied 3 days a week for 3 months and each participant will participate in a total of 36 exercise sessions individually. It is anticipated that revealing the cognitive, physical, neurophysiological, and biochemical effects of aerobic, strengthening, and home exercise practices in individuals with chronic neck pain and explaining the similarities and superiorities of different exercise practices will pave the way for planning targeted health services.

Interventions

• Other Aerobic exercise
  Participants 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
• Other Strengthening exercise
  A 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
• Other Posture and strentching exercise
  Posture 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.

Primary outcome measures

• Pain Intensity [Time frame: Baseline, 6th week, and 12th week]

Eligibility criteria

Inclusion criteria

• 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
• Right hand dominancy according to Edinburgh Handedness Inventory
• Having at least a primary school graduate

Exclusion criteria

• 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
• Presence of materials in the body such as jewelry, metal, hearing aid, pacemaker, lead that cannot be removed and are not suitable for MRI
• History of neck or shoulder surgery
• Being pregnant or having given birth within the last year

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Turkey (Türkiye) · 1 center

• Hacettepe University Faculty of Physical Therapy and Rehabilitation — Ankara

Identifiers

NCT: NCT07432425 · KA-23031

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗