Combining motivational and volitional strategies to promote unsupervised walking in patients with fibromyalgia

Combining motivational and volitional strategies to promote unsupervised walking in patients with fibromyalgia: a randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN68584893

Enrollment

582

Registered

2013-12-09

Start date

2012-09-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibromyalgia Musculoskeletal Diseases Fibromyalgia

Interventions

The intervention is based on two well-established theories for predicting behavior. One group will receive a motivational plus implementation intention intervention, a second group will receive only a

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Women aged between 18-70 years old 2. Fit London-4 criteria for fibromyalgia (London Fibromyalgia Epidemiology Study Screening Questionnaire: White et al., 1999; Branco et al., 2010) 3. Medical recommendation to walk

Exclusion criteria

Exclusion criteria: Comorbidity which impedes walking

Design outcomes

Primary

Measure	Time frame
Two primary outcomes will be assessed as an indicator of the intervention effect on exercise adherence: 1. Proportion of participants who perform the full minimum walking criteria at the end of the period of 6 weeks, and the proportion of participants who maintain it at 3 and 9 months 2. Among participants who perform the full minimum walking criteria, we will focus on the proportion who reaches the recommended pattern for fibromyalgia patients at week 6 We will use self-reported measurements, self-reported items and daily logs, and a pedometer.	—

Measure

Time frame

Two primary outcomes will be assessed as an indicator of the intervention effect on exercise adherence: 1. Proportion of participants who perform the full minimum walking criteria at the end of the period of 6 weeks, and the proportion of participants who maintain it at 3 and 9 months 2. Among participants who perform the full minimum walking criteria, we will focus on the proportion who reaches the recommended pattern for fibromyalgia patients at week 6 We will use self-reported measurements, self-reported items and daily logs, and a pedometer.

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Secondary

Measure	Time frame
1. 6-minute Walk Test (6-MWT): the 6-MWT is a clinically relevant measure of the physical function that the Spanish Rheumatology Society recommends using with fibromyalgia patients 2. The short self-administered Spanish version of the International Physical Activity Questionnaire (s-IPAQ) 3. Fibromyalgia impact: Spanish adaptation of the Fibromyalgia Impact Questionnaire (FIQ) 4. Pain: total score of an 11-point numerical rating scale (NRS) (0 = 'no pain at all' and 10 = 'the worst pain you can imagine') 5. Emotional status: Spanish adaptation of the Hospital Anxiety and Depression Scale (HAD) s-IPAQ , FIQ , NRS and HAD will be assessed in the first, second and third year	—

Measure

Time frame

1. 6-minute Walk Test (6-MWT): the 6-MWT is a clinically relevant measure of the physical function that the Spanish Rheumatology Society recommends using with fibromyalgia patients 2. The short self-administered Spanish version of the International Physical Activity Questionnaire (s-IPAQ) 3. Fibromyalgia impact: Spanish adaptation of the Fibromyalgia Impact Questionnaire (FIQ) 4. Pain: total score of an 11-point numerical rating scale (NRS) (0 = 'no pain at all' and 10 = 'the worst pain you can imagine') 5. Emotional status: Spanish adaptation of the Hospital Anxiety and Depression Scale (HAD) s-IPAQ , FIQ , NRS and HAD will be assessed in the first, second and third year

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Countries

Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 8, 2026