NCT05485220

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

June 20, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 3, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

August 3, 2022

Status Verified

July 1, 2022

Enrollment Period

1.5 years

First QC Date

February 20, 2022

Last Update Submit

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

EXPERIMENTAL

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

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)

Other: High-intensity interval training

control group

NO INTERVENTION

the 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.

aerobic exercise group

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.

High intensity interval training group

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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)

RECRUITING

MeSH Terms

Conditions

Neck Pain

Interventions

ExerciseHigh-Intensity Interval Training

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaPhysical Conditioning, Human

Central Study Contacts

sinem ayyıldız çinar

CONTACT

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

Locations