The Effects of Arm Ergometer Endurance Training and High-intensity Interval Training in Chronic Neck Pain
1 other identifier
interventional
51
1 country
1
Brief Summary
Neck pain is among the causes of morbidity that causes disability. Although it is not life-threatening, neck pain is one of the most important reasons for a decrease in the workforce. Since there is a close anatomical, musculoskeletal and neural connection between the cervical region and the thoracic spine, neck pain can affect respiratory functions by causing biomechanical changes in the thoracic spine and rib cage. The aim of this study is to investigate the effects of aerobic exercise and high-intensity interval training, which are known to have an effect on both the musculoskeletal system and respiratory functions, on the respiratory parameters and musculoskeletal system disorders and clinical outcomes of people with neck pain when applied with an arm ergometer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 20, 2022
CompletedStudy Start
First participant enrolled
June 20, 2022
CompletedFirst Posted
Study publicly available on registry
August 3, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedAugust 3, 2022
July 1, 2022
1.5 years
February 20, 2022
July 31, 2022
Conditions
Outcome Measures
Primary Outcomes (12)
neck pain
participants' neck pain perception with visual analog pain scale. 0= no pain, 10=maximum pain
8 weeks
Spirometer measurements 1
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
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
(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
Forced Expiratory Flow (FEF%25-75) with spirometer (Spirolab III, Spirolab, Medical International Research)
8 weeks
MIP-MEP
maximal expiratory pressure (MEP) and maximal inspiratory pressure (MIP) with respiratory pressure meter (Micro Medical MicroMPM).
8 weeks
chest circumference measurement
chest circumference measurement with a tape measure.
8 weeks
Cervical Joint Range of Motion
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
Cervical Joint Position Error Test with Cervical Range of Motion - 3 (Performance Attainment Associates, St. Paul, MN, 55117, United States) (CROM 3).
8 weeks
Activation and endurance of deep cervical flexor muscles
Activation and endurance of deep cervical flexor muscles with Stabilizer Pressure Biofeedback.
8 weeks
craniovertebral angle
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
8 weeks
hand grip strength
Hand grip strength with Jamar Hydraulic Hand Dynamometer.
8 weeks
Study Arms (3)
aerobic exercise group
EXPERIMENTALthe participants do aerobic training by an arm crank ergometer (Monark 881E Upper and Lower Body Ergometer)
High intensity interval training group
EXPERIMENTALthe participants do High intensity interval training by an arm crank ergometer (Monark 881E Upper and Lower Body Ergometer)
control group
NO INTERVENTIONthe participants don't do any exercises
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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,
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sinem Ayyıldız Çinar
Ankara, 06000, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle Investigator
Study Record Dates
First Submitted
February 20, 2022
First Posted
August 3, 2022
Study Start
June 20, 2022
Primary Completion
December 31, 2023
Study Completion
December 31, 2023
Last Updated
August 3, 2022
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will not share