NCT05401513

Brief Summary

The purpose of this study is to analyze the effects of an exercise program, based on the Pilates method, on the low back pain and muscle fatigue of Brazilian Air Force helicopter pilots.

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
16

participants targeted

Target at below P25 for not_applicable low-back-pain

Timeline
Completed

Started Jun 2022

Shorter than P25 for not_applicable low-back-pain

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 29, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 2, 2022

Completed
18 days until next milestone

Study Start

First participant enrolled

June 20, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

June 6, 2022

Status Verified

June 1, 2022

Enrollment Period

3 months

First QC Date

May 29, 2022

Last Update Submit

June 2, 2022

Conditions

Keywords

low back painphysiotherapymuscle fatigue

Outcome Measures

Primary Outcomes (1)

  • Painful sensation

    To compare the painful sensation in the lumbar region using the Numerical Pain Rating Scale (NPRS) across a range of 11, with 0 being described as 'no pain' and 10 as 'worst possible pain'.

    Change from baseline in low back pain sensation at 6 weeks and 12 weeks after the intervention protocol

Secondary Outcomes (2)

  • Functional disability associated to back pain

    Change from baseline in disability at 6 weeks and 12 weeks after the intervention protocol

  • Back muscle fatigue

    Change from baseline in back muscle fatigue at 6 weeks and 12 weeks after the intervention protocol

Study Arms (2)

Pilates Group

EXPERIMENTAL

12-weeks exercise program, twice a week, with Pilates method exercises.

Other: Pilates Group

Control Group

NO INTERVENTION

12-weeks maintaining their normal physical activity routine.

Interventions

The individuals of the Pilates group will perform specific exercises of the method, which will involve mobility, stability and muscular resistance. The exercises will progress according to the level of difficulty (basic, intermediate and advanced), load and repetition every three or four weeks.

Pilates Group

Eligibility Criteria

Age20 Years - 38 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Brazilian Air Force helicopter instructors - Natal Air Base;
  • Nonspecific low back pain for more than 3 months with a score of 2 or more at Numerical Pain Rating Scale.

You may not qualify if:

  • Be undergoing physiotherapeutic treatment during the study period;
  • Corticosteroids treatment in the last two weeks;
  • Anti-inflammatory treatment in the previous 72 hours;
  • Have specific spinal pathologies, such as spondylitis, spondylolysis, spondylolisthesis, disc herniation with radiculopathy or those who have had spinal surgery in the last year or who have a recent history of spinal fracture.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Rio Grande do Norte

Natal, Rio Grande do Norte, 59140-840, Brazil

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Jamilson Simões Brasileiro, PhD

CONTACT

Lidiane Cristina Correia Bulhões, Msc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 29, 2022

First Posted

June 2, 2022

Study Start

June 20, 2022

Primary Completion

September 30, 2022

Study Completion

November 1, 2022

Last Updated

June 6, 2022

Record last verified: 2022-06

Locations