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

July 31, 2022 updated by: Sinem Ayyıldız Çinar, Hacettepe University

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

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.

Study Overview

Status

Recruiting

Conditions

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

Interventional

Enrollment (Anticipated)

51

Phase

  • 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 Locations

      • Ankara, Turkey, 06000
        • Recruiting
        • Sinem Ayyıldız Çinar
        • Contact:

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

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

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
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

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.
8 weeks
Cervical Joint Range of Motion
Time Frame: 8 weeks
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
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
Time Frame: 8 weeks
Activation and endurance of deep cervical flexor muscles with Stabilizer Pressure Biofeedback.
8 weeks
craniovertebral angle
Time Frame: 8 weeks
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
Time Frame: 8 weeks
Hand grip strength with Jamar Hydraulic Hand Dynamometer.
8 weeks

Collaborators and Investigators

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

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)

June 20, 2022

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

February 20, 2022

First Submitted That Met QC Criteria

July 31, 2022

First Posted (Actual)

August 3, 2022

Study Record Updates

Last Update Posted (Actual)

August 3, 2022

Last Update Submitted That Met QC Criteria

July 31, 2022

Last Verified

July 1, 2022

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)?

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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