NCT03166995

Brief Summary

In the current study, the investigators aimed to study:

  • The proprioception status of patients with FMS.
  • The effectiveness of a postural exercise program in women with fibromyalgia for 8 weeks (2 sessions per week), compared to a low impact aerobic exercise program on different parameters, such as proprioception, balance, muscle strength, flexibility and joint range.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2017

Shorter than P25 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

May 23, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 25, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

September 4, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 29, 2017

Completed
Last Updated

April 4, 2018

Status Verified

April 1, 2018

Enrollment Period

2 months

First QC Date

May 23, 2017

Last Update Submit

April 3, 2018

Conditions

Fibromyalgia

Keywords

Fibromyalgia,postural exercises

Outcome Measures

Primary Outcomes (1)

  • Proprioception

    Proprioception will be evaluated at baseline and at the end of the study possible differences between women with fibromyalgia and healthy women using an isokinetic device (BIODEX MULTI-JOINT SYSTEM - PRO). The following movements were analized: knee (flexion, extension), hip (flexion, extension, abduction, adduction), ankle (flexion, extension), shoulder (flexion, extension). Joint position sense for knee extension and shoulder flexion will be also performed.

    8 weeks

Secondary Outcomes (9)

  • Balance

    8 weeks

  • Handgrip strength

    8 weeks

  • Joint range of motion

    8 weeks

  • Pain

    8 weeks

  • Leisure Time Physical Activity

    8 weeks

  • +4 more secondary outcomes

Study Arms (3)

Experimental group 1

EXPERIMENTAL

Low impact aerobic exercise group. 1hour, twice a week

Other: Low impact aerobic exercise

Experimental group 2

EXPERIMENTAL

Postural exercises group. 1hour, twice a week

Other: Postural exercises

Control propriocepcion

NO INTERVENTION

No exercise, just proprioceptive control.

Interventions

Low impact aerobic exerciseOTHER

The intervention will consist of working the muscles that are most affected by FMS through group exercises, which will be dynamic, fluid and aimed at improving functionality. Each session will consist of 60 minutes and will be divided into three parts: warm up (15 minutes); games, group dynamics and aerobics (30 minutes); and cool down with stretching for 15 minutes.

Experimental group 1
Postural exercisesOTHER

The intervention will consist of performing postural exercises in prone, supine, sitting and standing position, as well as in quadrupedia. Each session will consist of 60 minutes and will be divided into three parts: warm up (15 minutes); postural exercises (30 minutes); and cool down with stretching for 15 minutes.

Experimental group 2

Eligibility Criteria

Age30 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged between 30 and 65 years.
  • Meeting ACR 2010 criteria for FMS.

You may not qualify if:

  • Medical contraindication for physical activity.
  • Deafness or limited hearing.
  • Vestibular disorders that compromise balance.
  • Low vision or blindness.
  • Psychotic disorder or cognitive impairment.
  • Decompensation or changes in medication.
  • Surgical interventions in the last six months.
  • Rheumatic disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physiotherapy, University of Valencia

Valencia, 46010, Spain

Location

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • Marta Inglés, PhD

    Faculty of Physiotherapy. University of Valencia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

May 23, 2017

First Posted

May 25, 2017

Study Start

September 4, 2017

Primary Completion

November 10, 2017

Study Completion

December 29, 2017

Last Updated

April 4, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)