Exercise Protocol for Pilots With Back Pain.

NCT ID: NCT03713814

Last Updated: 2019-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-01
• Study Completion Date: 2019-07-10

Brief Summary

It is known that the low back pain can cause discomfort and deconcentration during the flight, requests for abstention of flight, fear in the aviators about the future in case of illness and economic damages to the country. However, there are few studies about the incidence, prevalence or risk factors associated with low back pain in Brazilian air force pilots. Also, the literature lacks further randomized controlled studies about interventions, leaving a huge field to be explored in future research.

Objectives: This study to analyze the chronic effects of an exercise protocol on lumbar pain in Brazilian Air Force pilots.

Materials and methods: The study is a blind and randomized clinical trial, in which a protocol of strength and lumbar resistance exercises will be tested. The volunteers will be: 20 fighter instructors with intermittent low back pain. Such volunteers will be recruited in a non-probabilistic manner for convenience. Moreover, they will be randomly distributed through www.randomization.com to form two groups with 10 members each: experimental group (EG), where they will participate in an exercise program three times a week for 8 weeks; and the control group (CG), in which they will receive explanation and handbook demonstration of the same exercises (Appendix 1) - after 8 weeks of intervention and after being reevaluated.

The study will be performed at the city of Natal/ Rio Grande do Norte. The evaluation will consist of an evaluation form with personal data, anthropometric data, occupational information, health history, physical exercise pattern and pain information, quantified by Visual Analog Pain Scale. In addition, the Oswestry questionnaire will be administered to assess lumbar function and the Nordic Questionnaire to assess musculoskeletal changes. Also, will be done: postural evaluation, using a postural evaluation software (SAPO); assessment of lumbar range of motion, using an IPHONE app called iHandy Level; Magnetic Resonance Imaging of the spine; dynamometry to measure the trunk extension force, flexion with rotation and lateral bridge, using the manual dynamometer Lafayette® - model 01165, USA; and resistance test of trunk stabilizing muscles. Magnetic resonance imaging will be done at the Onofre Lopes University Hospital. The project will be submitted to the Research Ethics Committee of the Federal University of Rio Grande do Norte through the national interface "Plataforma Brasil". The study will also be registered on the international clinical trial platform, ClinicalTrials.gov.

Data analysis: The Statistical Package for Social Science (SPSS) software will be used in the analysis. The normality of data distribution and the homogeneity of the variances will be verified by the Kolmogorov-Smirnov (K-S) and Levine tests, respectively. If there is a normal distribution, the descriptive statistics will be performed through means and standard deviations. Significance level adopted: 5% (P <0.05). The paired t test was used for the comparisons between the measurements obtained in the pre and post 2 month evaluations, and for the comparison between the groups (CG and EG), the unpaired t test. If the data do not present a normal distribution, the Friedman test will be used for comparisons of the measures of the evaluations in each group and the Kruskal-Wallis test for comparisons between the groups (CG and EG).

Conditions

Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Experimental Group

8-week exercise program, three times a week, during 45 minutes each section. Exercises for strength, endurance and mobility of the spine using pilates´ball and mat.

Group Type: EXPERIMENTAL

Exercise

Intervention Type: OTHER

8-week exercise program, three times a week, during 45 minutes each section. Exercises for strength, endurance and mobility of the spine using pilates´ball and mat.

The researcher will explain, demonstrate and supervise the participants. It will start with 10 minutes of warming-up using a ergometer bicycle, followed by the mat exercises. Some of these will require motor control with mobility, others will require isometry, or concentric and eccentric phases with progression of eccentric phase timing.

Control group

After the 8 weeks of intervention, the pilots will receive explanation and handbook demonstration of the same exercises.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Exercise

8-week exercise program, three times a week, during 45 minutes each section. Exercises for strength, endurance and mobility of the spine using pilates´ball and mat.

The researcher will explain, demonstrate and supervise the participants. It will start with 10 minutes of warming-up using a ergometer bicycle, followed by the mat exercises. Some of these will require motor control with mobility, others will require isometry, or concentric and eccentric phases with progression of eccentric phase timing.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Subject is fight pilot.
• Subject is flight instructor from the Brazilian Air Force.

Exclusion Criteria

• Had not flown in the last 3 months
• History of acute lower back pain in the week of the evaluation
• Physical therapy during the study period
• History of heart disease or uncontrolled hypertension
• History of neurological disease
• History of rheumatic disease
• History of diabetes
• Do not perform the evaluation procedures correctly.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Universidade Federal do Rio Grande do Norte

OTHER

Sponsor Role: lead

Responsible Party

Jamilson Simões Brasileiro

Professor of Physiotherapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Federal University of Rio Grande do Norte

Natal, Rio Grande do Norte, Brazil

Countries

Brazil

References

Mendes PRF, Gomes SRA, Costa LDO, Liguori ADAL, Bulhoes LCC, Brasileiro JS. Core stabilisation exercises reduce chronic low back pain in Air Force fighter pilots: a randomised controlled trial. BMJ Mil Health. 2024 Jan 25;170(1):31-36. doi: 10.1136/bmjmilitary-2021-002005.

Reference Type: DERIVED

PMID: 35470256 (View on PubMed)

Other Identifiers

PSLD2018

Identifier Type: -

Identifier Source: org_study_id