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

February 19, 2026 updated by: Songül Atasavun UYSAL, Hacettepe University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
21

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Turkey (Türkiye)
    • Altindag
      • Ankara, Altindag, Turkey (Türkiye)
        • Recruiting
        • Hacettepe University Faculty of Physical Therapy and Rehabilitation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Aerobic exercise group
Aerobic exercise training will be applied 3 days a week for 3 months and each participant will participate in a total of 36 exercise sessions individually.
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 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)
Experimental: Strengthening exercise group
Strengthening exercise training will be applied 3 days a week for 3 months and each participant will participate in a total of 36 exercise sessions individually.
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), 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)
Other: Posture and stretching exercise group
Posture and stretching exercise training will be applied 3 days a week for 3 months and each participant will participate in a total of 36 exercise sessions individually as the control intervention.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain Intensity
Time Frame: Baseline, 6th week, and 12th week
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.
Baseline, 6th week, and 12th week

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Global Cognition
Time Frame: Baseline and 12th week
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.
Baseline and 12th week
Biochemical Measurements
Time Frame: Baseline and 12th week
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.
Baseline and 12th week
Neuromaging
Time Frame: Baseline and 12th week
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.
Baseline and 12th week
Cognitive Functions
Time Frame: Baseline and 12th week
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.
Baseline and 12th week
Cognitive Functions
Time Frame: Baseline and 12th week
The Stroop Test is a brief measure of selective or focused attention, the ability to switch from one perceptual state to another in the test and to inhibit cognitive interference. It measures concentration and the ability to resist distractions. A Turkish standardization study was conducted and its norms were determined.
Baseline and 12th week
Cognitive Functions
Time Frame: Baseline and 12th week
Standardized Mini Mental Test is used to determine cognitive level. The validity and reliability study of the test in Turkish was conducted. The scores that can be obtained from the test can vary between 0 and 30 points. The cut-off score for mild and moderate dementia in our country was reported as 23/24.
Baseline and 12th week
Pittsburgh Sleep Quality Index
Time Frame: Baseline and 12th week
The Turkish validity and reliability of the scale were established. The scale is a 19-item scale consisting of 7 components that assess sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disorders, sleep medication use, and daytime functional impairment. Some components consist of a single item, while others are grouped together. Each item is scored between 0 and 3 points. The total scale score ranges from 0 to 21, with higher scores indicating poor sleep quality.
Baseline and 12th week
Pressure Pain Thresholds
Time Frame: Baseline, 6th week, and 12th week
To objectively assess central sensitization, the pressure pain thresholds of the volunteers will be evaluated. A digital algometer will be used for this measurement. A symptomatic local region (middle trapezius muscle midway between the spinous process of C7 and the lateral border of the acromion) and at asymptomatic distant region (quadriceps muscle midway between the anterior superior iliac spine and the basis patellae) will be measured.
Baseline, 6th week, and 12th week
Central Sensitization Inventory
Time Frame: Baseline and 12th week
This scale was developed for the purpose of evaluating central sensitization. The Turkish validity and reliability study of the scale was conducted. The scale consists of 2 sections, A and B. Section A consists of 25 questions that inquire about the frequency of symptoms that may be associated with central sensitization, while Section B inquires whether the patient has been diagnosed by a physician with a disease thought to be associated with central sensitization, and if so, on what date. Each question is scored from never (0) to always (4). The highest possible score on the scale is 100. An increase in the score on the scale indicates a more severe central sensitization.
Baseline and 12th week
Tampa Kinesiophobia Scale
Time Frame: Baseline and 12th week
This scale was developed to assess fear of movement and re-injury to the affected area. The Turkish validity and reliability study of the questionnaire was conducted. The scale uses a 4-point Likert scale (Strongly Disagree=1, Disagree=2, Agree=3, Strongly Agree=4). To calculate the questionnaire score, items 4, 8, 12, and 16 are reversed, and the scores are summed. The total score obtainable from the scale ranges from 17 to 68 points. A higher score indicates a more severe form of kinesiophobia.
Baseline and 12th week
Pain Catastrophizing Scale
Time Frame: Baseline and 12th week
This scale was developed to assess the level of a person's pain catastrophizing. The Turkish validity and reliability study of the questionnaire was conducted. The scale consists of 13 questions, and each question is scored between 0 and 4 (0=Never, 1=Somewhat, 2=Moderately, 3=Severely, 4=Always). The total score that can be obtained from the scale is between 0 and 52 points. A higher score indicates more severe catastrophizing.
Baseline and 12th week
Two-Minute Walk Test
Time Frame: Baseline, 6th week, and 12th week
This test was developed as an alternative to the 6-minute walk test. The 2-Minute Walk Test is used as an indicator of physical capacity. The distance walked by volunteers after 2 minutes will be calculated and recorded.
Baseline, 6th week, and 12th week
Muscle Strength
Time Frame: Baseline, 6th week, and 12th week
A digital dynamometer will be used to assess the isometric strength of the neck muscles. Lovett's muscle test positions will be applied for dynamometric isometric muscle strength measurement. Cervical flexor, cervical extensor, cervical lateral flexor, shoulder flexor, shoulder extensor, shoulder abductor, shoulder horizontal abductor, shoulder horizontal adductor, shoulder internal rotator, shoulder external rotator, elbow flexor, and elbow extensor muscles will be measured. Each measurement will be performed 3 times, and the average value will be recorded in Newtons.
Baseline, 6th week, and 12th week
Neck Disability Index
Time Frame: Baseline and 12th week
This scale was developed to assess the degree of neck disability in individuals. The Turkish validity and reliability of the scale were established. The scale evaluates subjective symptoms and activities of daily living. Items are scored between 0 (no limitation) and 5 (maximum limitation). Based on the total score, 0-4 points indicate no disability, 5-14 points mild, 15-24 points moderate, 25-34 points severe, and 35-50 points complete functional impairment.
Baseline and 12th week
Edinburgh Handedness Inventory
Time Frame: Baseline
This questionnaire is a frequently used scale to determine dominant hand. It questions the hand(s) used in 10 daily living activities, including writing, drawing, throwing, using scissors, using a toothbrush, using a knife without a fork, using a spoon, sweeping with a broom, lighting a match, and opening a box. Scoring is done on a scale of -100 (left hand) to +100 (right hand). Individuals scoring above 40 are classified as right-handed; those scoring between 40 and -40 are classified as ambidextrous (actively using both hands); and those scoring -40 and below are classified as left-handed. A Turkish reliability study of the questionnaire was conducted.
Baseline
Demogrphic Data Collection Form
Time Frame: Baseline
A demographic data collection form will be used to record the volunteers' age, gender, height, weight, education level, years of education, smoking status, and occupation information. After obtaining the volunteers' occupation information, they will be scored according to the occupational scores. According to this scoring system, Level 1 includes people without an occupation. Level 2 includes private household chores, service occupations, transportation, and material handling. Level 3 includes sales occupations, administrative support, protective services, farming, and machine operators. Level 4 includes technicians and precision manufacturing workers. Level 5 includes executive, administrative, and managerial services. Level 6 includes professional specialty occupations.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hacettepe University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Ahmet Ilkay Isikay, Associate Professor, Faculty of Medicine, Department of Neurosurgery, Hacettepe University
  • Study Chair: Asli Pinar, Professor, Faculty of Medicine, Department of Medical Biology, Hacettepe University
  • Study Chair: Ezgi Yetim Arsava, PhD, Faculty of Medicine, Department of Neurology, Hacettepe University
  • Study Chair: Erdem Karabulut, Professor, Faculty of Medicine, Department of Biostatistics, Hacettepe University
  • Study Chair: Rahsan Gocmen, Associate Professor, Faculty of Medicine, Department of Radiology, Hacettepe University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 25, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 25, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 25, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KA-23031

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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