- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05485220
The Effects of Arm Ergometer Endurance Training and High-intensity Interval Training in Chronic Neck Pain
The Effects of Arm Ergometer Endurance Training and High-intensity Interval Training on Respiratory Parameters, Musculoskeletal System, and Clinical Symptoms in Chronic Neck Pain
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Patients will be divided into 3 groups as randomized controlled. Aerobic exercise will be applied to the first group and HIIT to the second group. The third group will be the control group.
The patients in the first group will be applied an aerobic exercise program with an arm ergometer. Peak workload will be determined by performing an exercise test with an arm ergometer and training will be given for 60-70% of the peak workload for 45 minutes with arm ergometer 3 days a week for 8 weeks.
HIIT with arm ergometer will be applied to the patients in the second group. Peak workload will be determined by performing an exercise test with an arm ergometer, and HIIT will be performed with an arm ergometer for 45 minutes in total, 90-95% of peak workload for 30 seconds, 60 seconds in between, active recovery at 40-50% workload. After the patients receive training for 8 weeks, 3 times a week, post-treatment evaluations will be made.
Only evaluations will be made twice, with an interval of 8 weeks, for the patients in the control group.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: sinem ayyıldız çinar
- Phone Number: 05068916464
- Email: sinem.ayyildiz@hacettepe.edu.tr
Study Locations
-
-
-
Ankara, Turkey, 06000
- Recruiting
- Sinem Ayyıldız Çinar
-
Contact:
- sinem ayyıldız çinar
- Phone Number: 05068916464
- Email: ayyildizsnm@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male and female patients between the ages of 18-55,
- Having neck pain for more than 3 months,
- Having neck pain ≥3 cm in a 10 cm VAS and
- Patients with non-specific neck pain who score > 10/50 on the Neck Disability Index will be included.
Exclusion Criteria:
- Pregnant women,
- Smokers,
- BMI>40
- Those with any cardiovascular or pulmonary disease,
- Those who cannot exercise due to any medical condition,
- Those who have received physical therapy for neck pain in the last 6 months,
- Red flag (malignancy, spinal fracture, etc.),
- Spinal fracture,
- Shoulder fracture,
- Shoulder subluxation,
- Cervical or shoulder surgery,
- Migraine,
- Rheumatological diseases,
- Those with cervical root compression syndrome,
- Those with neurological/inflammatory spinal pathology,
- Those with chronic whiplash and traumatic neck injury,
- Persons with <24 points on the mini-mental test.
Study Plan
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 |
Intervention / Treatment |
---|---|
Experimental: aerobic exercise group
the participants do aerobic training by an arm crank ergometer (Monark 881E Upper and Lower Body Ergometer)
|
Aerobic exercise group: Peak workload will be determined by performing an exercise test on the patients.
Training will be given at 60-70% of the peak workload for 45 minutes with an arm ergometer 3 days a week for 8 weeks.
|
Experimental: High intensity interval training group
the participants do High intensity interval training by an arm crank ergometer (Monark 881E Upper and Lower Body Ergometer)
|
High-intensity interval training Group: Peak workload will be determined by performing an exercise test on the patients and arm ergometer HIIT will be done with a total of 45 minutes, 90-95% of the peak workload for 30 seconds, 60 seconds in between, active recovery at 40-50% workload, 3 days a week for 8 weeks.
|
No Intervention: control group
the participants don't do any exercises
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
neck pain
Time Frame: 8 weeks
|
participants' neck pain perception with visual analog pain scale.
0= no pain, 10=maximum pain
|
8 weeks
|
Spirometer measurements 1
Time Frame: 8 weeks
|
Forced Expiratory Volume during the first second (FEV1) with spirometer (Spirolab III, Spirolab, Medical International Research) (FEV1 and FVC will be combined to report FEV1/FVC)
|
8 weeks
|
Spirometer measurements 2
Time Frame: 8 weeks
|
Forced Vital Capacity (FVC) with spirometer (Spirolab III, Spirolab, Medical International Research) (FEV1 and FVC will be combined to report FEV1/FVC)
|
8 weeks
|
Spirometer measurements 3
Time Frame: 8 weeks
|
(FEV1/FVC) with spirometer (Spirolab III, Spirolab, Medical International Research) (FEV1 and FVC will be combined to report FEV1/FVC)
|
8 weeks
|
Spirometer measurements 4
Time Frame: 8 weeks
|
Forced Expiratory Flow (FEF%25-75) with spirometer (Spirolab III, Spirolab, Medical International Research)
|
8 weeks
|
MIP-MEP
Time Frame: 8 weeks
|
maximal expiratory pressure (MEP) and maximal inspiratory pressure (MIP) with respiratory pressure meter (Micro Medical MicroMPM).
|
8 weeks
|
chest circumference measurement
Time Frame: 8 weeks
|
chest circumference measurement with a tape measure.
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8 weeks
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Cervical Joint Range of Motion
Time Frame: 8 weeks
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Cervical Joint Range of Motion with Cervical Range of Motion - 3 (Performance Attainment Associates, St. Paul, MN, 55117, United States) (CROM 3).
|
8 weeks
|
Cervical Joint Position Error Test
Time Frame: 8 weeks
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Cervical Joint Position Error Test with Cervical Range of Motion - 3 (Performance Attainment Associates, St. Paul, MN, 55117, United States) (CROM 3).
|
8 weeks
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Activation and endurance of deep cervical flexor muscles
Time Frame: 8 weeks
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Activation and endurance of deep cervical flexor muscles with Stabilizer Pressure Biofeedback.
|
8 weeks
|
craniovertebral angle
Time Frame: 8 weeks
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Craniovertebral angle will be measured by taking 2 lateral photographs of the subject.
Spinous process of C7 and the tragus of ear will be marked with a body marker.
A horizontal line is drawn passing through C7 making a right angle with the vertical.
Then, the angle between the line connecting C7 spinous process with the tragus of the ear and the horizontal line, will measured using a goniometer
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8 weeks
|
hand grip strength
Time Frame: 8 weeks
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Hand grip strength with Jamar Hydraulic Hand Dynamometer.
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8 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KA-21111
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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