van Eijk-Hustings et al. Fibromyalgia randomised controlled trial

[Dolphin]

I'm interested in this for a slightly obscure reason - the talk of compliance with an aerobic exercise intervention

"As willingness to participate in AE was limited, this group has been analysed but interpretation of the data is considered arguable."

I'm interested in compliance in graded activity/exercise in ME/CFS trials which often isn't assessed or only minimally assessed e.g. compliance can be achieved by simply turning up for meetings with therapist.

Challenges in demonstrating the effectiveness of multidisciplinary treatment on quality of life, participation and health care utilisation in patients with fibromyalgia: a randomised controlled trial
Clinical Rheumatology
2012, DOI: 10.1007/s10067-012-2100-7Online First™
Published in partnership with the

International League of Associations for Rheumatology
ORIGINAL ARTICLE

Yvonne van Eijk-Hustings, Mariëlle Kroese, Frans Tan, Annelies Boonen, Monique Bessems-Beks and Robert Landewé

Abstract

This study aimed to examine the effectiveness of a multidisciplinary intervention with aftercare (MD) compared to aerobic exercise (AE) and usual care (UC) in recently diagnosed patients with fibromyalgia (FM). In a Zelen-like design, eligible patients from the outpatient rheumatology clinics of three medical centres in the South of the Netherlands were consecutively recruited and pre-randomised to MD (n = 108), AE (n = 47) or UC (n = 48). MD consisted of a 12-week course of sociotherapy, physiotherapy, psychotherapy and creative arts therapy (three half days per week), followed by five aftercare meetings in 9 months. AE was given twice a week in a 12-week course. UC varied but incorporated at least education and lifestyle advice. Primary outcomes were health-related quality of life (HR-Qol), participation and health care utilisation. Secondary outcome was the Fibromyalgia Impact Questionnaire (FIQ). Total follow-up duration of the study was 21–24 months. As willingness to participate in AE was limited, this group has been analysed but interpretation of the data is considered arguable. Within the MD group, a statistically significantly improved HR-Qol and a statistically significant reduction in number of hours sick leave, number of contacts with general practitioners and number of contacts with medical specialists was found. Moreover, statistically significant improvements were found on the FIQ, which increased after the intervention. However, no statistically significant between-group differences were found at the endpoint of the study. MD seemed to yield positive effects, but firm conclusions with regard to effectiveness cannot be formulated due to small between-group differences and limitations of the study.
Keywords Early diagnosis – Fibromyalgia – Randomised controlled trial – Treatment outcome
Trial registration: ISRCTN32542621.

 

[Esther12]

Ta D. Was the full paper revealing?

 

[Dolphin]

Ta D. Was the full paper revealing?

Don't have it, I'm afraid.

But have seen other interesting stuff in previous FM papers e.g. the trial below, which was found to have poor compliance when they looked at the activity logs. After they reassigned people based on the activity logs,

impact of FM on current health status decreased in the low-intensity group (P < 0.05) and increased in the high-intensity group (P < 0.02) weeks 0-24.

Utilizing exercise to affect the symptomology of fibromyalgia: a pilot study.

Abstract

Meyer BB, Lemley KJ


Department of Human Kinetics, University of Wisconsin-Milwaukee, 53201, USA. bbmeyer@uwm.edu
Medicine and Science in Sports and Exercise [2000, 32(10):1691-1697]
Type: Clinical Trial, Controlled Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't

DOI: 10.1097/00005768-200010000-00005

Abstract

Fibromyalgia (FM), a rheumatological disorder of unknown origin, is characterized by both physical and psychological symptoms. Although inconclusive results have been reported for most treatment modalities, exercise appears to have universal support for decreasing the myriad of symptoms associated with FM. Weaknesses in the literature, however, prevent conclusive statements regarding exercise prescription and concomitant impact on FM symptomology.

PURPOSE: The current pilot study attempted to examine the effect of a 24-wk walking program at predetermined intensities on FM.

METHODS: Initial design was a randomized control trial with high- and low-intensity exercise groups, and a control group. Subsequent nonrandomized control trials were based on actual exercise behavior.

RESULTS: No differences between initial groups were identified. By collapsing groups, heart rate (HR) decreased (P < 0.05) weeks 0-12. Functional impairments were reduced 54% weeks 0-24, with exercise having a large impact (omega2 = 0.30) on this decrease. By reassigning groups, impact of FM on current health status decreased in the low-intensity group (P < 0.05) and increased in the high-intensity group (P < 0.02) weeks 0-24. Omega squared indicated strong influence of exercise on pain (omega2 = 0.51), with greater pain in the high-intensity group.

CONCLUSIONS: A larger number of subjects and direct supervision of the training program to increase compliance is necessary to clarify the effects of a walking program on the manifestations of FM. Results indicate that intensity of the walking program is an important consideration. Individuals with FM can adhere to low-intensity walking programs two to three times per week, possibly reducing FM impact on daily activities.

(PMID:11039639)

 

[Esther12]

Thanks D.

I've not read much FMS stuff.

 

[Dolphin]

Thanks D.

I've not read much FMS stuff.

Me neither, although I've a feeling that a certain percentage of people in FMS trials have ME/CFS. This is interesting for various reasons e.g. if I was a biomedical researcher, one place to look for ideas for things that might occur in ME/CFS would be abnormalities found in FMS. Not saying they all will apply but I'd say some might.

 

[Dolphin]

Not sure if anyone is interested, but I found a full copy here:
http://www.researchgate.net/publica..._controlled_trial/file/9fcfd5079bcf3327e5.pdf