Primary Objective: To study the association between muscle characteristics (contractile, morphological,biochemical, and histological) and the response to high- and low-load exercise training on muscle strength in patients with rheumatoid arthritis (…
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameter is the difference in isokinetic muscle strength
pre- and post-intervention in all three patient groups. Quadricepsstrength
(isokinetic, BIODEX)
Secondary outcome
- A set of biomarkers obtained by muscle biopsy and blood that characterize
muscle quality in terms of energy management, histology (architecture), gene
expression and inflammation.
- Feasibility: therapy adherence, drop-out rate, user satisfaction, Net
Promoter score (Reichheld 2003)
- Subject characteristics (age, gender, height, weight, comorbidity (CIRS),
medication, educational level, employment, marital status, smoking and alcohol
use, duration symptoms, use of walking devices
- Anthropometrics: BMI, absolute & relative muscle mass (Bio Impedance
Analysis). Short-form mini- nutritional assessment (MNA-SF, Rubenstein 2001).
- Disease characteristics: diagnosis, radiologic severity RA/OA
- Performance: Muscle endurance (Biodex), Handgrip strength (JAMAR),Short
Physical Performance Battery (SPPB), Six Minute Walking Test (6MWT), FITMAX
survey, Meijer 2021), PROMIS short form-CAT pain, fatigue, physical function,
social function.
- Muscle architecture (by ultrasound) Volume, CSA, muscle pennation angle,
fascicle length.
Background summary
C4M hypothesizes that patients with low muscle strength may respond differently
to different types of exercise intervention, dependent on the underlying
aetiology, i.e. impaired protein synthesis versus metabolic dysfunction. This
response is related to various clinical, blood-based, and muscle metabolic and
architectural biomarkers and the clinical diagnosis, i.e., rheumatoid arthritis
(RA), osteoarthritis (OA), and sarcopenia alone (SARC). Understanding the
underlying biochemical muscle characteristics of each diagnosis group can help
to develop more targeted training in making it more effective.
Study objective
Primary Objective: To study the association between muscle characteristics
(contractile, morphological,biochemical, and histological) and the response to
high- and low-load exercise training on muscle strength in patients with
rheumatoid arthritis (RA), osteoarthritis (OA), and sarcopenia(SARC)."
Secondary objectives: To investigate the effectiveness of high- and low-load
exercise on muscle endurance andclinical outcomes in patients with rheumatoid
arthritis (RA), osteoarthritis (OA), and sarcopenia (SARC) and, focusing on
muscular contractile, morphological, biochemical,histological characteristics,
and their interaction with the three diseases."
s.
Study design
two-arm parallel-group exploratory trial including a total of 69 patients
Intervention
Exercise intervention 2 times a week for 8 weeks on location and once a week at
home
Study burden and risks
The participant burden consists of 2 parts:
1) Measurements at baseline and follow-up. The patients are asked to go to
Amsterdam UMC and/or Reade once for a biopsy and blood collection, 3D ultra
sound m.quadriceps, muscle strength test m. quadriceps and a short
questionnaire is administered with questions regarding physical and social
functioning and perceived fatigue. Duration: in total about 150 minutes
2) The intervention/training itself. This is performed in the context of
regular care, i.e. patients with low muscle strength (dynapenia according to
the EWSOP criteria) who are eligible for exercise therapy. Unlike regular care,
the form of the exercise therapy given is determined in advance, with the total
load remaining roughly the same. Patients participating in the study will be
required to come to Reade twice a week for eight weeks to complete the exercise
program.
de Boelenlaan 1117
Amsterdam 1081 HV
NL
de Boelenlaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
For all patients:
Willingness and motivation to exercise. Low muscle strength defined as hand
grip strength (HGS) <27 kg and <16 kg for males and females respectively. If
HGS is not possible due to interfering pain or joint- deformity, the chair
stand test is used instead, with low muscle strength defined as not able to
rise from the chair without arms or a time >15 sec (Cruz Jentoft 2019).
- Gait speed of >0.8m/s to exclude patients who are too disabled to participate
in the study (Cruz Jentoft 2019).
Osteoarthritis patients
- Ages between 50 and 70
- Patients with either knee and/or hip osteoarthritis according to clinical
American College of Rheumatology criteria (Altman 1986).
- Kellgren and Lawrence (K&L) grading score of 2-4 for hip and/or knee OA.
- C-reactive Protein (CRP) levels <10mg/L within 3 months prior to enrolment
Rheumatoid arthritis patients
- Ages between 50 and 70
- Diagnosed with RA according to EULAR/ ACR criteria (Aletaha 2010).
- Disease activity score (DAS28) 2.8<5.6, as defined by the EULAR criteria
(Aletaha 2010), either de novo or despite Disease-Modifying Antirheumatic Drug
(DMARD) therapy.
- Stable disease three months prior to the start of the exercise intervention.
- Stable rheumatic medications three months prior to the start of the exercise
intervention.
- Stopped the usage of corticosteroids 3 months prior to the start of the
exercise intervention.
- Disease duration >1 year and <15 years
Sarcopenia patients
- Ages between 50 and 80.
- Sarcopenia without joint involvement (no OA, RA), according to the EWGSOPII
criteria (Cruz Jentoft 2019) of low muscle strength defined as hand grip
strength (HGS) <27 kg and <16 kg for males and females respectively
(dynapenia). This group will therefore involve primarily involve participants
with probable sarcopenia (dynapenia) but may also encompass participants with
confirmed sarcopenia (appendicular muscle Lean Mass (ALM)/height2 <7.0 kg/m2
for males and <5.5 kg/m2 for females) as this is no selection criterion. Severe
sarcopenia will be excluded (gait speed < 0,8 m/s).
- Exclude patients with Joint complaints (RA, OA, or other joint disease).
Exclusion criteria
BMI < 18 and > 35 Kg/m2
Contra-indications for exercise testing and prescription are on the basis of
theanswers from the *physical activity readiness questionnaire* (PAR-Q) and
familiarity(by self-report) of the following heart conditions: heart failure
symptoms, myocardialinfarction less than three months before the start of the
training program anddiagnosed with other cardiac diseases
Participants taking beta-blockers for the duration of the intervention.
Diagnosed with other neurologic or cachectic diseases or major surgery that may
interfere with muscle quality (i.e. multiple sclerosis, ongoing cancer
treatment or radiotherapy/ chemotherapy in the previous 6 months).
Participating in another regular and intense (> 2 times a week) physical
training programme within 2 months prior to enrolment.
Ligament/muscle tear and/or other injuries within 6 months.
Taking drugs (e.g. performance enhancing drugs) or nutritional supplements
(e.g. protein powder) known to increase muscle mass.
Inability to be scheduled for exercise therapy
Insufficient comprehension of Dutch language or no informed consent.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL86908.018.24 |