Condition category
Musculoskeletal Diseases
Date applied
10/03/2016
Date assigned
16/03/2016
Last edited
16/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Fibromyalgia is a long term (chronic) condition that causes pain all over the body. Other symptoms include an increased sensitivity to pain, feeling extremely tired, stiff muscles, difficulty sleeping, problems with memory and concentration, headaches and irritable bowel syndrome. There isn’t a cure for the condition, but the symptoms can be alleviated though, for example, medication, counselling and exercise. The aim of this study is investigate the effect of a 20 week exercise programme, called a Standard Physical Rehabilitation Intervention (SPRI) program, taking place in in a pool or in the gym for women with light or moderate symptoms of fibromyalgia.

Who can participate?
Women aged between 30-59 and diagnosed with fibromyalgia.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in group 1 do an exercise programme in the gym for 20 weeks, involving two 50 minute sessions every week. Those in group 2 do an exercise programme in the pool for 20 weeks, involving two 50 minute sessions every week. All participants are assessed every two weeks where they have their heart rate and weight measured, are asked about their level of pain, and mood, undergo respiratory and aerobic function tests and are asked about how their fibromyalgia is affecting them at that time.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
International University of Catalunya (Spain)

When is the study starting and how long is it expected to run for?
September 2011 to January 2013

Who is funding the study?
International University of Catalunya (Spain)

Who is the main contact?
Dr Alfonso Castillo-Rodriguez
acastillo@ugr.es

Trial website

Contact information

Type

Public

Primary contact

Dr Alfonso Castillo-Rodriguez

ORCID ID

http://orcid.org/0000-0002-2723-8970

Contact details

Ctra. Alfacar s/n
Granada
18011
Spain
0034958244377
acastillo@ugr.es

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Multidisciplinary study in chronic muscle pain

Acronym

Study hypothesis

To assess the effect of a Standard Physical Rehabilitation Intervention (SPRI) program, in pool-based (SPRI-P) and land-based (SPRI-L) environments, applied to women patients with light to moderate symptoms (FIQ<70) during a period of 20 weeks.

Ethics approval

International University of Catalunya, 12/09/2011

Study design

Interventional open controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Fibromyalgia

Intervention

The program duration was 20 weeks with two 50-minute sessions each week (with a 2 day interval between in order to avoid muscle fatigue). The patients were divided into four groups, two in a Standard Physical Rehabilitation Intervention program in pool-based environment and two in a Standard Physical Rehabilitation Intervention program in land-based environment, accommodating the personal schedule of each patient.

Warm-up:
Each session began with a 10-minute warm-up which consisted of activities based primarily on walking (slower or faster). Participants were asked to walk sideways or backwards, to change their pace, or to pass a ball between them while walking, etc.

Activity:
This was the most important part of the SPRI program, and consisted of a mix of activities based on aerobic exercise, strength, proprioception, balance, and breathing. The principal of progressive load increase was taken into consideration, and the patients never attained high intensity workloads. This period lasted approximately 25 minutes.

Stretching:
At the end of the activity period, stretching was performed for about 10 minutes, with a focus on the muscles most used.

Relaxation:
The session ended with approximately 10 minutes of relaxation with an emphasis on controlled breathing.

Intervention type

Phase

Drug names

Primary outcome measures

Muscle pain, measured using the Fibromyalgia Impact Questionnaire (FIQ)., assessed at baseline and after 4 weeks

Secondary outcome measures

1. Heart rate, measured by Heart Rate Monitor Polar RC3
2. Weight
3. Self-perceived pain, measured by the visual analog scale (VAS) used to measure the intensity of self-perceived pain by the patient. This instrument was also used to measure the intensity of perceived fatigue by the patient.
4. Respiratory and aerobic function, measured by the six minute walk test (6MW)
5. Depression, measured using the Hamilton depression scale (HAM-D)
6. Overall impact of fibromyalgia using the FIQ.

All measured every two weeks for 20 weeks

Overall trial start date

13/09/2011

Overall trial end date

18/01/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Female
2. Aged between 30 to 59 years
3. Have an accredited medical certificate with an established diagnosis of FM according to the American College of Rheumatology
4. Have a light to moderate degree of impairment due to FM (FIQ less than 70)
5. Capable of walking without aid

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

120

Participant exclusion criteria

1. Suffering from an unstable cardiovascular pathology or any other medical condition that impedes physical exercise
2. History of fractures of the upper or lower members during the last three months
3. Suffering from neuromuscular disease or ingestion of drugs which affect neuromuscular function
4. Presence of any serious or terminal illness, history of myocardial infarction during the last three months
5. In litigation with management for recognition of occupational disability

Recruitment start date

13/09/2011

Recruitment end date

13/11/2011

Locations

Countries of recruitment

Spain

Trial participating centre

International University of Catalunya
08017
Spain

Sponsor information

Organisation

International University of Catalunya

Sponsor details

Alfa & Beta buildings Immaculada
22
Barcelona
08017
Spain

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

International University of Catalunya

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Intention to publish date

31/12/2016

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes