NCT00383084

Brief Summary

The purpose of this study is to determine the effect of 3 months of daily, 30-minute lifestyle physical activity on pain and fatigue in inactive adults with fibromyalgia (FM).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2006

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

September 29, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 2, 2006

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

July 1, 2013

Completed
Last Updated

September 15, 2017

Status Verified

August 1, 2017

Enrollment Period

3.8 years

First QC Date

September 29, 2006

Results QC Date

January 29, 2013

Last Update Submit

August 17, 2017

Conditions

Fibromyalgia

Keywords

PainPhysical ActivityFatigueLifestyle Activity

Outcome Measures

Primary Outcomes (2)

  • Ambulatory Pain (Higher Values Indicate Greater Pain)

    0 to 100 pain rating, higher numbers indicate greater pain

    Baseline and after 12-weeks

  • Ambulatory Fatigue, Higher Values Indicate Greater Fatigue

    0-100 fatigue ratings, higher scores indicative of greater levels of fatigue

    Baseline and after 12-weeks

Secondary Outcomes (2)

  • Number of Tender Points on the Body

    Baseline and after 12-weeks

  • Functional Capacity (Higher Scores Indicative of Poorer Functioning)

    Baseline and after 12-weeks

Study Arms (2)

1

EXPERIMENTAL

Group 1 participants will take part in 30 minutes total of self-selected lifestyle physical activity throughout the day, 5 to 7 days per week. Twice a month, they will attend group sessions designed to help participants develop and maintain a more physically active lifestyle. Goal setting, self-monitoring, and pain management will be discussed at these sessions.

Behavioral: Lifestyle physical activity (LPA)

2

ACTIVE COMPARATOR

Group 2 participants will attend monthly fibromyalgia educational sessions, which will focus on understanding the symptoms of FM, learning to manage pain and fatigue, and developing self-help strategies.

Behavioral: Fibromyalgia education

Interventions

Lifestyle physical activity (LPA)BEHAVIORAL

Bi-weekly, 60-minute group sessions spread over 12 weeks. Participants will receive education on how to increase their daily physical activity, goal setting, problem solving strategies to overcome barriers to being more physically active, and finding new ways to integrate short bouts of LPA into their daily lives.

1
Fibromyalgia educationBEHAVIORAL

Participants will meet monthly for 1.5 to 2 hours for a total of 3 months. The sessions will be divided into three components: (1) education, (2) question and answer, and (3) social support.

2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Meets American College of Rheumatology (ACR) criteria for FM
  • Inactive at study entry
  • Willing to become more physically active
  • Understands and willing to follow study recommendations regarding lifestyle modification
  • Able to participate in the study for 2 years
  • Agrees to not make any changes to current FM-related treatments

You may not qualify if:

  • Any comorbidity that may worsen a participant's physical functioning, independent of FM (e.g., significant cardiovascular disease, history of arrhythmias, morbid obesity, autoimmune diseases, uncontrolled or untreated hypertension, significant renal or prostate disease, stroke, seizure disorder, any other significant neurological diseases)
  • Significant peripheral neuropathy
  • Any current psychiatric disorder that involves a history of psychosis, including schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, bipolar disorder, or severe personality disorder. Participants with mood disorder are not excluded.
  • Alcohol or substance abuse within the 2 years prior to study entry
  • Current suicide risk or suicide attempt within the 2 years prior to study entry
  • Severe physical disability that may interfere with physical activity
  • Currently participates in structured exercise or plans to participate in an exercise program
  • Any investigational medications or devices within 4 weeks prior to study entry
  • Any expected life change, such as relocation, within the next 2 years that may prevent study participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21221, United States

Location

Related Publications (6)

  • Culos-Reed SN, Brawley LR. Fibromyalgia, physical activity, and daily functioning: the importance of efficacy and health-related quality of life. Arthritis Care Res. 2000 Dec;13(6):343-51. doi: 10.1002/1529-0131(200012)13:63.0.co;2-p.

    PMID: 14635309BACKGROUND

  • Karper WB, Jannes CR, Hampton JL. Fibromyalgia syndrome: the beneficial effects of exercise. Rehabil Nurs. 2006 Sep-Oct;31(5):193-8. doi: 10.1002/j.2048-7940.2006.tb00135.x.

    PMID: 16948441BACKGROUND

  • Oliver K, Cronan TA. Correlates of physical activity among women with fibromyalgia syndrome. Ann Behav Med. 2005 Feb;29(1):44-53. doi: 10.1207/s15324796abm2901_7.

    PMID: 15677300BACKGROUND

  • Campbell CM, McCauley L, Bounds SC, Mathur VA, Conn L, Simango M, Edwards RR, Fontaine KR. Changes in pain catastrophizing predict later changes in fibromyalgia clinical and experimental pain report: cross-lagged panel analyses of dispositional and situational catastrophizing. Arthritis Res Ther. 2012 Oct 25;14(5):R231. doi: 10.1186/ar4073.

    PMID: 23098173DERIVED

  • Fontaine KR, Conn L, Clauw DJ. Effects of lifestyle physical activity in adults with fibromyalgia: results at follow-up. J Clin Rheumatol. 2011 Mar;17(2):64-8. doi: 10.1097/RHU.0b013e31820e7ea7.

    PMID: 21325963DERIVED

  • Fontaine KR, Conn L, Clauw DJ. Effects of lifestyle physical activity on perceived symptoms and physical function in adults with fibromyalgia: results of a randomized trial. Arthritis Res Ther. 2010;12(2):R55. doi: 10.1186/ar2967. Epub 2010 Mar 30.

    PMID: 20353551DERIVED

MeSH Terms

Conditions

FibromyalgiaPainMotor ActivityFatigue

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Results Point of Contact

Title
Kevin Fontaine, PhD
Organization
Johns Hopkins University
kfontai1@jhmi.edu
443-449-4314

Study Officials

  • Kevin Fontaine, PhD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restriction Type
LTE60

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2006

First Posted

October 2, 2006

Study Start

September 1, 2006

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

September 15, 2017

Results First Posted

July 1, 2013

Record last verified: 2017-08

Locations

US(1)