Trial · NCT07432425
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pain Intensity | 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. |
| Other | Global Cognition | 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. |
| Other | Biochemical Measurements | 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. |
| Other | Neuromaging | 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. |
| Other | Cognitive Functions | 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. |
| Other | Cognitive Functions | 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. |
| Other | Cognitive Functions | 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. |
| Other | Pittsburgh Sleep Quality Index | 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. |
| Other | Pressure Pain Thresholds | 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. |
| Other | Central Sensitization Inventory | 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. |
| Other | Tampa Kinesiophobia Scale | 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. |
| Other | Pain Catastrophizing Scale | 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. |
| Other | Two-Minute Walk Test | 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. |
| Other | Muscle Strength | 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. |
| Other | Neck Disability Index | 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. |
| Other | Edinburgh Handedness Inventory | 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. |
| Other | Demogrphic Data Collection Form | 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. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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