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

Primary Purpose

Neck Pain

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Aerobic exercise
High-intensity interval training
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sinem Ayyıldız ÇinarRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

aerobic exercise group

High intensity interval training group

control group

Arm Description

the participants do aerobic training by an arm crank ergometer (Monark 881E Upper and Lower Body Ergometer)

the participants do High intensity interval training by an arm crank ergometer (Monark 881E Upper and Lower Body Ergometer)

the participants don't do any exercises

Outcomes

Primary Outcome Measures

neck pain
participants' neck pain perception with visual analog pain scale. 0= no pain, 10=maximum pain
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)
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)
Spirometer measurements 3
(FEV1/FVC) with spirometer (Spirolab III, Spirolab, Medical International Research) (FEV1 and FVC will be combined to report FEV1/FVC)
Spirometer measurements 4
Forced Expiratory Flow (FEF%25-75) with spirometer (Spirolab III, Spirolab, Medical International Research)
MIP-MEP
maximal expiratory pressure (MEP) and maximal inspiratory pressure (MIP) with respiratory pressure meter (Micro Medical MicroMPM).
chest circumference measurement
chest circumference measurement with a tape measure.
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).
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).
Activation and endurance of deep cervical flexor muscles
Activation and endurance of deep cervical flexor muscles with Stabilizer Pressure Biofeedback.
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
hand grip strength
Hand grip strength with Jamar Hydraulic Hand Dynamometer.

Secondary Outcome Measures

Full Information

First Posted
February 20, 2022
Last Updated
July 31, 2022
Sponsor
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT05485220
Brief Title
The Effects of Arm Ergometer Endurance Training and High-intensity Interval Training in Chronic Neck Pain
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 20, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
51 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
aerobic exercise group
Arm Type
Experimental
Arm Description
the participants do aerobic training by an arm crank ergometer (Monark 881E Upper and Lower Body Ergometer)
Arm Title
High intensity interval training group
Arm Type
Experimental
Arm Description
the participants do High intensity interval training by an arm crank ergometer (Monark 881E Upper and Lower Body Ergometer)
Arm Title
control group
Arm Type
No Intervention
Arm Description
the participants don't do any exercises
Intervention Type
Other
Intervention Name(s)
Aerobic exercise
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
High-intensity interval training
Intervention Description
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.
Primary Outcome Measure Information:
Title
neck pain
Description
participants' neck pain perception with visual analog pain scale. 0= no pain, 10=maximum pain
Time Frame
8 weeks
Title
Spirometer measurements 1
Description
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)
Time Frame
8 weeks
Title
Spirometer measurements 2
Description
Forced Vital Capacity (FVC) with spirometer (Spirolab III, Spirolab, Medical International Research) (FEV1 and FVC will be combined to report FEV1/FVC)
Time Frame
8 weeks
Title
Spirometer measurements 3
Description
(FEV1/FVC) with spirometer (Spirolab III, Spirolab, Medical International Research) (FEV1 and FVC will be combined to report FEV1/FVC)
Time Frame
8 weeks
Title
Spirometer measurements 4
Description
Forced Expiratory Flow (FEF%25-75) with spirometer (Spirolab III, Spirolab, Medical International Research)
Time Frame
8 weeks
Title
MIP-MEP
Description
maximal expiratory pressure (MEP) and maximal inspiratory pressure (MIP) with respiratory pressure meter (Micro Medical MicroMPM).
Time Frame
8 weeks
Title
chest circumference measurement
Description
chest circumference measurement with a tape measure.
Time Frame
8 weeks
Title
Cervical Joint Range of Motion
Description
Cervical Joint Range of Motion with Cervical Range of Motion - 3 (Performance Attainment Associates, St. Paul, MN, 55117, United States) (CROM 3).
Time Frame
8 weeks
Title
Cervical Joint Position Error Test
Description
Cervical Joint Position Error Test with Cervical Range of Motion - 3 (Performance Attainment Associates, St. Paul, MN, 55117, United States) (CROM 3).
Time Frame
8 weeks
Title
Activation and endurance of deep cervical flexor muscles
Description
Activation and endurance of deep cervical flexor muscles with Stabilizer Pressure Biofeedback.
Time Frame
8 weeks
Title
craniovertebral angle
Description
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
Time Frame
8 weeks
Title
hand grip strength
Description
Hand grip strength with Jamar Hydraulic Hand Dynamometer.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
sinem ayyıldız çinar
Phone
05068916464
Email
sinem.ayyildiz@hacettepe.edu.tr
Facility Information:
Facility Name
Sinem Ayyıldız Çinar
City
Ankara
ZIP/Postal Code
06000
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
sinem ayyıldız çinar
Phone
05068916464
Email
ayyildizsnm@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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