The Effects of Arm Ergometer Endurance Training and High-intensity Interval Training in Chronic Neck Pain

Neck Pain Clinical Trial

Official title:

The Effects of Arm Ergometer Endurance Training and High-intensity Interval Training on Respiratory Parameters, Musculoskeletal System, and Clinical Symptoms in Chronic Neck Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05485220
• Other study ID #: KA-21111
• Status: Recruiting
• Phase: N/A
• Start date: June 20, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: July 2022
• Source: Hacettepe University
• Contact: sinem ayyildiz çinar
• Phone: 05068916464
• Email: sinem.ayyildiz[@]hacettepe.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 51
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neck Pain

Intervention

Other:
• Aerobic exercise
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
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.

Locations

Country	Name	City	State
Turkey	Sinem Ayyildiz Çinar	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	neck pain	participants' neck pain perception with visual analog pain scale. 0= no pain, 10=maximum pain	8 weeks
Primary	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
Primary	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
Primary	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
Primary	Spirometer measurements 4	Forced Expiratory Flow (FEF%25-75) with spirometer (Spirolab III, Spirolab, Medical International Research)	8 weeks
Primary	MIP-MEP	maximal expiratory pressure (MEP) and maximal inspiratory pressure (MIP) with respiratory pressure meter (Micro Medical MicroMPM).	8 weeks
Primary	chest circumference measurement	chest circumference measurement with a tape measure.	8 weeks
Primary	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
Primary	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
Primary	Activation and endurance of deep cervical flexor muscles	Activation and endurance of deep cervical flexor muscles with Stabilizer Pressure Biofeedback.	8 weeks
Primary	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
Primary	hand grip strength	Hand grip strength with Jamar Hydraulic Hand Dynamometer.	8 weeks