Aquatic Exercises for Patients With Chronic Low Back Pain | NCT02422693

Studies
Aquatic Exercises for Patients With Chronic Low Back Pain

NCT02422693

Sponsor

Universidade Estadual de Londrina

Status

Completed

Last Update Posted

Jul 11, 2017Actual

Enrollment

120Actual

Phase

Not Applicable

Conditions

Chronic Low Back Pain

Interventions

Aquatic Exercises
Deep-water running

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 29, 2015Actual

Primary Completion Date

Jan 29, 2017Actual

Completion Date

May 10, 2017Actual

First Submitted Date

Apr 6, 2015

First Submission Date that Met QC Criteria

Apr 20, 2015

First Posted Date

Apr 21, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 5, 2017

Last Update Posted Date

Jul 11, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jefferson Rosa Cardoso, PT, PhD, Universidade Estadual de LondrinaPrincipal Investigator

Lead Sponsor

Universidade Estadual de LondrinaOTHER

Collaborators

Name	Class
Ministry of Health, Brazil	OTHER_GOV
Fundação Araucária	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of this study is to compare the effect of aquatic exercises (AEG) to the aquatic exercises plus aerobic training (deep-water running) (AEDWRG) on functional status and pain in patients with specific chronic low back pain.

Detailed Description

In general, the population will have at least one episode of low back pain during their lifetime, with recurrence in most cases. Several treatments have been proposed for these patients and the evidence is still not clear about the effectiveness of aquatic exercises when compared to other modalities of exercises in the water. This study will be a randomized controlled trial following the Consort-Statement principles. The subjects, aged between 20 and 50 years, after signing the informed consent will be randomly allocated to one group treatment: aquatic exercises (AEG) or aquatic exercises associated to deep-water running (AEDWRG). The duration of the protocol will be set at 12 weeks, 3x-week.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Aquatic exercises	Experimental	Warm-up, lumbar mobilization, stretching and relaxation. 3x-week (9 weeks), indoor pool, 32o.C/89.6o.F.	Other: Aquatic Exercises
Aquatic exercises + Deep-water running	Active Comparator	Same as AEG with addition of 20 minutes of running without touch the ground, 3x-week (9 weeks), indoor pool, 30o.C/86o.F.	Other: Aquatic Exercises Other: Deep-water running

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Aquatic Exercises	Other	Exercises performed in the water.	Aquatic exercises Aquatic exercises + Deep-water running

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Roland-Morris Questionnaire	Functionality	baseline and 9 weeks

Secondary Outcomes

Measure	Description	Time Frame
Change in Pain status	Pain	baseline and 9 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Exclusive diagnosis of chronic low back pain (more than 12 weeks)

Exclusion Criteria:

Central nervous system disease
Pregnant
Fear of water

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jefferson R Cardoso, PT, PhD	Universidade Estadual de Londrina	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aquatic Physical Therapy Center "Paulo A. Seibert"		Londrina	Paraná	86038440	Brazil

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided