Neck PainNCT05485220
The Effects of Arm Ergometer Endurance Training and High-intensity Interval Training in Chronic Neck Pain
A study testing Aerobic exercise and High-intensity interval training in people with Neck Pain, run by Hacettepe University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Aerobic exercise and High-intensity interval training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jun 2022to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 17Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Sinem Ayyıldız Çinar
Ankara, 06000
sinem ayyıldız çinar, 05068916464, ayyildizsnm@gmail.com
About this study
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
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.
Read the 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.
- Conditions
- Neck Pain
- Being tested
- Aerobic exercise, High-intensity interval training
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exerciseOther
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 trainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| aerobic exercise group | Experimental | the participants do aerobic training by an arm crank ergometer (Monark 881E Upper and Lower Body Ergometer) Receives: Other: Aerobic exercise |
| High intensity interval training group | Experimental | the participants do High intensity interval training by an arm crank ergometer (Monark 881E Upper and Lower Body Ergometer) Receives: Other: High-intensity interval training |
| control group | No intervention | the participants don't do any exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
neck pain
participants' neck pain perception with visual analog pain scale. 0= no pain, 10=maximum pain
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 8 weeks
Spirometer measurements 4
Forced Expiratory Flow (FEF%25-75) with spirometer (Spirolab III, Spirolab, Medical International Research)
Measured: 8 weeks
MIP-MEP
maximal expiratory pressure (MEP) and maximal inspiratory pressure (MIP) with respiratory pressure meter (Micro Medical MicroMPM).
Measured: 8 weeks
chest circumference measurement
chest circumference measurement with a tape measure.
Measured: 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).
Measured: 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).
Measured: 8 weeks
Activation and endurance of deep cervical flexor muscles
Activation and endurance of deep cervical flexor muscles with Stabilizer Pressure Biofeedback.
Measured: 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
Measured: 8 weeks
hand grip strength
Hand grip strength with Jamar Hydraulic Hand Dynamometer.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2022
- Study start20 Jun 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sinem Ayyıldız Çinar, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05485220
- Sponsor's protocol ID
- KA-21111
- Status last verified
- Jul 2022
- First submitted
- 20 Feb 2022
- Last updated
- 3 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05485220
- Acronym / sponsor ID
- KA-21111
- Conditions
- Neck Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 20 Jun 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 3 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| aerobic exercise group | Experimental | Other: Aerobic exercisethe participants do aerobic training by an arm crank ergometer (Monark 881E Upper and Lower Body Ergometer) |
| High intensity interval training group | Experimental | Other: High-intensity interval trainingthe participants do High intensity interval training by an arm crank ergometer (Monark 881E Upper and Lower Body Ergometer) |
| control group | No intervention | –the participants don't do any exercises |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (17 listed)
- Pregnant women,
- Smokers,
- BMI>40
- Those with any cardiovascular or pulmonary disease,
- Those who cannot exercise due to any medical condition,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic exerciseAerobic 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. | Other | aerobic exercise group |
| High-intensity interval trainingHigh-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. | Other | High intensity interval training group |
Primary outcome
neck pain
Time frame: 8 weeks
participants' neck pain perception with visual analog pain scale. 0= no pain, 10=maximum pain
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)
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)
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)
Spirometer measurements 4
Time frame: 8 weeks
Forced Expiratory Flow (FEF%25-75) with spirometer (Spirolab III, Spirolab, Medical International Research)
MIP-MEP
Time frame: 8 weeks
maximal expiratory pressure (MEP) and maximal inspiratory pressure (MIP) with respiratory pressure meter (Micro Medical MicroMPM).
chest circumference measurement
Time frame: 8 weeks
chest circumference measurement with a tape measure.
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).
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).
Activation and endurance of deep cervical flexor muscles
Time frame: 8 weeks
Activation and endurance of deep cervical flexor muscles with Stabilizer Pressure Biofeedback.
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
hand grip strength
Time frame: 8 weeks
Hand grip strength with Jamar Hydraulic Hand Dynamometer.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercise and High-intensity interval training in people with Neck Pain, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact sinem ayyıldız çinar (05068916464, sinem.ayyildiz@hacettepe.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
neck pain (time frame: 8 weeks). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2022.