NCT02422693

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

April 6, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 21, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

June 29, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 29, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2017

Completed
Last Updated

July 11, 2017

Status Verified

July 1, 2017

Enrollment Period

1.6 years

First QC Date

April 6, 2015

Last Update Submit

July 5, 2017

Conditions

Chronic Low Back Pain

Keywords

hydrotherapyaquatic

Outcome Measures

Primary Outcomes (1)

  • Change in Roland-Morris Questionnaire

    Functionality

    baseline and 9 weeks

Secondary Outcomes (1)

  • Change in Pain status

    baseline and 9 weeks

Study Arms (2)

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 ExercisesOther: Deep-water running

Interventions

Aquatic ExercisesOTHER

Exercises performed in the water.

Also known as: Aquatic Physical Therapy
Aquatic exercisesAquatic exercises + Deep-water running
Deep-water runningOTHER

It is a non-impact form of running executed in place in (higher than 2 meters) the water wearing a flotation belt. Heart rate is controlled by heart rate watch

Aquatic exercises + Deep-water running

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Central nervous system disease
  • Pregnant
  • Fear of water

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aquatic Physical Therapy Center "Paulo A. Seibert"

Londrina, Paraná, 86038440, Brazil

Location

Study Officials

  • Jefferson R Cardoso, PT, PhD

    Universidade Estadual de Londrina

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 6, 2015

First Posted

April 21, 2015

Study Start

June 29, 2015

Primary Completion

January 29, 2017

Study Completion

May 10, 2017

Last Updated

July 11, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)