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29 August 2008
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| [ Print-friendly version ] |
| High Intensity Training in patients with rheumatoid arthritis |
| ISRCTN | ISRCTN62313758 |
| ClinicalTrials.gov identifier | |
| Public title | High Intensity Training in patients with rheumatoid arthritis |
| Scientific title | High Intensity Training in rheumatoid arthritis (RA)-molecular pathways related to inflammation, fatigue and pain |
| Acronym | HIT-study |
| Serial number at source | N/A |
| Study hypothesis |
The overall aim of the present study is to explore the underlying mechanisms of muscle weakness, inflammation, and pain with particular reference to the role of muscle strength in females with early rheumatoid arthritis (RA) by investigating the effects of high-intensity strength training on clinical variables, systemic and local molecular expression, and pathophysiological pain mechanisms.
Specific research questions are: 1. What are the effects of a twelve-week high intensity muscle strength training program on muscle strength, pain, fatigue and general health perception? (Hypothesis I) 2. Can training reduce C-reactive protein (CRP) levels in serum? (Hypothesis II) 3. Can training reduce the number of swollen joints? (Hypothesis II) 4. Can training decrease gene expression of inflammatory molecules in peripheral blood and in muscle tissue? (Hypothesis II) 5. Can training affect the phenotype of peripheral blood cells (of special interest the CD28 null T cells)? (Hypothesis II) 6. Can training have a positive effect on metabolic changes in muscle tissue? (Hypothesis III) 7. Can training affect concentration of reactive oxygen species (ROS) and reduced mitochondrial density in muscle tissue of RA patients? (Hypotheses II and III) 8. Is the expression of oestrogen receptors in muscle tissue different between patients with RA and healthy controls? (Hypothesis IV) 9. Can training alter the expression of oestrogen receptor? (Hypothesis V) 10. Is increased pain sensitivity at baseline related to the intensity of clinical pain? (Hypothesis VI) 11. Do increased pain sensitivity or a dysfunction of endogenous pain inhibitory controls at baseline predict poor treatment outcome following training? (Hypothesis VI) 12. Does training reduce pressure pain sensitivity and improve the function of endogenous pain inhibitory mechanisms? (Hypothesis VI) |
| Ethics approval | Ethics approval received from the Regional Research Ethics committee, Karolinska Institute, Stockholm on the 10th March 2008 (ref: 2008/243-32 2007/897-31). |
| Study design | Single-blind, randomised controlled trial (2 arms) |
| Countries of recruitment | Sweden |
| Disease/condition/study domain | Rheumatoid arthritis (RA) |
| Participants - inclusion criteria |
1. Twenty female patients after menopause
2. RA according to American College of Rheumatology criteria 3. Less than 12 months since diagnosis 4. Stable medication since at least three months 5. Independent in daily living 6. Passed menopause 7. Speak and understand Swedish 8. No other major disease that prevent them from performing intensive strength training |
| Participants - exclusion criteria | Does not comply with the above inclusion criteria. |
| Anticipated start date | 01/08/2008 |
| Anticipated end date | 01/08/2012 |
| Status of trial | Ongoing |
| Patient information material | |
| Target number of participants | Twenty females |
| Interventions |
The intervention group will participate in strength training three times a week in a 75-minute training program for 12 weeks. Eight major muscle groups will each be trained in three sets of eight repetitions at approximately 80% of maximum performance and a couple minutes of rest between each set. Each participant's maximum performance will be tested at baseline and every other week thereafter. Every training occasion starts with five minutes of warming up and ends with 10 minutes' cool down. Two weekly training sessions take place in training machines under the supervision of a physiotherapist. One weekly session is performed in the participants' home with the help of an instructive DVD and with their own body weight and rubber bands as resistance.
The control group continues their normal contacts with the health care, which during the time of the intervention does not include strength training. At the end of the intervention they will be offered the same strength training program. Patients will be followed up for three months for the intervention group and three months for the control group. |
| Primary outcome measure(s) |
Static and isokinetic muscle strength in knee extensors and knee flexors measured electronically with the Kin-Com.
Both the primary and the secondary outcomes will be measured at baseline and at three month follow up. |
| Secondary outcome measure(s) |
1. Clinical outcome (body functions, pain, fatigue and perceived health)
2. Inflammation 3. Pain mechanisms 4. Comorbidity 5. Muscle biopsies from vastus lateralis analysed for reactive oxygen species/reactive nitrogen species and expression of oestrogen receptors in muscles from patients with RA patients and controls before and after the intervention Both the primary and the secondary outcomes will be measured at baseline and at three month follow up. |
| Sources of funding | ALF Foundation (Sweden) (ref: 20070087 and 20080117) |
| Trial website | |
| Publications | |
| Contact name | Dr Birgitta Glenmark |
| Address |
Department of Clinical Science and Education
Södersjukhuset, KI |
| City/town | Stockholm |
| Zip/Postcode | SE 171 77 |
| Country | Sweden |
| Tel | +46 (0)8 601 5239 |
| Fax | +46 (0)8 601 5390 |
| birgitta.glenmark@ki.se | |
| Sponsor | ALF Foundation (Sweden) |
| Address |
FoUU-kansliet
Stockholms läns landsting Box 22550 |
| City/town | Stockholm |
| Zip/Postcode | 10422 |
| Country | Sweden |
| Tel | +46 (0)8 737 4841 |
| Fax | +46 (0)8 737 2998 |
| magnus.hammarberg@sll.se | |
| Sponsor website: | http://www.forskningsstod.sll.se |
| Date applied | 20/05/2008 |
| Last edited | 24/07/2008 |
| Date ISRCTN assigned | 24/07/2008 |
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