Trial Outcomes & Findings for Fibromyalgia and Specific Physical Activity (NCT NCT03895086)

Results Overview

Evolution of the Fibromyalgia Impact Questionnaire (FIQ) score (questionnaire of specific quality of life in the management of fibromyalgia patients) between the beginning of care (J0) and six months (M6). The scale score ranges from 0 to 100. The higher the score, the greater the difficulty in functioning and the severity of symptoms.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

1 participants

Primary outcome timeframe

6 months after randomization

Results posted on

2025-12-02

Participant Flow

Only 1 participant was randomized to the treatment

Participant milestones

Participant milestones
Measure	Specific Physical Activity Specific patient care in telephone coaching of fibromyalgia patients. Specific Physical Activity: An individual one hour face-to-face session conducted by adaptated physical activities teachers followed by eight telephone sessions by physical therapists and adaptated physical activities teachers (4 sessions each)	Classic Physical Activity Classic patient care in common group of multipathological patients. Classic Physical Activity: One session per week in groups conducted by adaptated physical activities teachers of "Siel Bleu" association
Overall Study STARTED	1	0
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Specific Physical Activity Specific patient care in telephone coaching of fibromyalgia patients. Specific Physical Activity: An individual one hour face-to-face session conducted by adaptated physical activities teachers followed by eight telephone sessions by physical therapists and adaptated physical activities teachers (4 sessions each)	Classic Physical Activity Classic patient care in common group of multipathological patients. Classic Physical Activity: One session per week in groups conducted by adaptated physical activities teachers of "Siel Bleu" association
Overall Study Early termination study	1	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Specific Physical Activity Specific patient care in telephone coaching of fibromyalgia patients. Specific Physical Activity: An individual one hour face-to-face session conducted by adaptated physical activities teachers followed by eight telephone sessions by physical therapists and adaptated physical activities teachers (4 sessions each)	Classic Physical Activity Classic patient care in common group of multipathological patients. Classic Physical Activity: One session per week in groups conducted by adaptated physical activities teachers of "Siel Bleu" association	Total Total of all reporting groups
Sex: Female, Male Female	—	—	0 Participants n=243 Participants
Sex: Female, Male Male	—	—	0 Participants n=243 Participants
Race and Ethnicity Not Collected	—	—	0 Participants n=243 Participants • Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 6 months after randomization

Population: Only one patient was enrolled in the study - data was not collected

Evolution of the Fibromyalgia Impact Questionnaire (FIQ) score (questionnaire of specific quality of life in the management of fibromyalgia patients) between the beginning of care (J0) and six months (M6). The scale score ranges from 0 to 100. The higher the score, the greater the difficulty in functioning and the severity of symptoms.

Outcome measures

Outcome data not reported

Adverse Events

Specific Physical Activity

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Classic Physical Activity

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mr Thomas RULLEAU

Maison de la Recherche en Santé

Phone: 6 35 55 03 35

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place