Contact information
Type
Scientific
Primary contact
Dr Birgitta Glenmark
ORCID ID
Contact details
Department of Clinical Science and Education
Södersjukhuset
KI
Stockholm
SE 171 77
Sweden
+46 (0)8 601 5239
birgitta.glenmark@ki.se
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
High Intensity Training in rheumatoid arthritis (RA)-molecular pathways related to inflammation, fatigue and pain
Acronym
HIT-study
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)
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Quality of life
Patient information sheet
Condition
Rheumatoid arthritis (RA)
Intervention
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.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
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 measures
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.
Overall trial start date
01/08/2008
Overall trial end date
01/08/2012
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Twenty females
Participant exclusion criteria
Does not comply with the above inclusion criteria.
Recruitment start date
01/08/2008
Recruitment end date
01/08/2012
Locations
Countries of recruitment
Sweden
Trial participating centre
Department of Clinical Science and Education
Stockholm
SE 171 77
Sweden
Sponsor information
Organisation
ALF Foundation (Sweden)
Sponsor details
FoUU-kansliet
Stockholms läns landsting
Box 22550
Stockholm
10422
Sweden
+46 (0)8 737 4841
magnus.hammarberg@sll.se
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
ALF Foundation (Sweden) (ref: 20070087 and 20080117)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary