|
Brief Summary
|
1.Background :
Rheumatoid
arthritis (RA) is a chronic debilitating condition that affects 0.5 to 1
percent of the Indian population (1). RA is characterized by chronic joint
inflammation, bony erosions, deformities, joint destruction, physical
disability and is associated with significant morbidity, premature mortality
and decline in the functional status of the patient (2). Major biological advances have been made in recent years, and
aggressive pharmacologic treatment has resulted in patient improvements.
However, not all patients respond effectively to treatment, and the use of some
biological agents has been associated with medical risks and socioeconomic
costs. Even when joint inflammation is medically controlled, some patients
experience RA-related disability, suggesting the utility of complementary
rehabilitation efforts, such as yoga.
A. Rationale : RA is
associated with altered body composition leading to reduction in fat-free mass,
higher body fat content is present even in the underweight and normal weight RA
patients.There is a higher incidence of centripetal obesity in RA patients, without any obvious change in
total body weight (3) In altered
body composition, BMI may not be a valid predictor of Body fat . Obesity is
a chronic inflammatory condition and it independently associates with
classical cardiovascular disease (CVD) risk factors in RA; RA patients are more
likely to have such CVD risk factors.For a given Body Fat content, patients
with RA have a significantly lower BMI, by almost 2 kg/m2 compared
with the general population.If BMI cut-offs of 23 % and 28 % are taken for
overweight and obesity similar to Asian-Indian population in whom body
composition is also altered, prevalence of higher overweight (∼45%) and obesity (∼37%) occurs among RA patients(4). Previous
studies have reported adipokines like Leptin, adiponectin, visfatin and
resistin, secreted from adipose tissue(5), are involved in the increased
production of proinflammatory agents like TNF-α, IL-1, IL-6 and CRP, which play important role
in the pathogenesis of RA.Central adiposity is associated with insulin
resistance and endothelial dysfunction in other
metabolic conditions like DM .Inspite of close associations of obesity
both with CVD risk and inflammation, as well as the body composition changes
observed in RA patients, there is paucity of data on the study of obesity and
body composition in RA patients. Incidence
of CV mortality has been reported higher in RA than in general population. Previous studies report that conventional CVD risk factors do not
fully explain excess CV morbidity and mortality in RA patients.In previous
studies, cardiovascular autonomic dysfunction has been reported around 61–75%
in RA patients(6). One
previous study done in AIIMS reported overactivity of sympathetic nervous
system and underactivity of parasympathetic nervous system in RA patients (7). The main pattern of dysfunction is impairment of cardiovascular
reflexes and altered HRV, indicative of reduced cardiac parasympathetic (strong
evidence) activity and elevated cardiac sympathetic activity (limited evidence). The literature up to date is underpowered to determine the causal
relationships between inflammation, ANS dysfunction, & adiposity in
RA.Other reports suggest that local inflammatory mediators like IL-1 and
TNF-alpha upregulate expression of adhesion molecules in endothelial cells
leading to endothelial dysfunction and leading to increase in CV
atherosclerosis & CVD events(8). Yoga is a
mind body technique involving breath control, physical exercise and meditation.
Beneficial in healthy subjects as well as in various diseases including auto
immune disorders, rheumatoid arthritis and osteoarthritis. An RCT from the USA compared a 6-week Iyengar yoga intervention twice
weekly with usual care. It included 30 young
women with RA. The RCT found no group differences in bodily pain on the SF-36
but Significant effects were reported for disability,pain(9). Another RCT
originating from India included 80 patients with RA , yoga intervention given
for 7 weeks compared with usual care, yoga significantly reduced pain on the
(SDPIS) Simple Descriptive Pain Intensity Scale (10). Similarly
few other small sized studies have reported that yoga therapy is beneficial on
the hand grip strength, Quality of Life, pain scores, immune parameters like
IL-6, depression and anxiety of rheumatoid arthritis patients (11,12,13). The evidence drawn from previous studies
of yoga therpay on RA is still limited due to low methodological quality and
outcome measures.
B. Novelty :
There is
paucity of data on the assessment and to find association, if any, between disease
activity, body
composition, cardiac autonomic functions, inflammatory, and oxidative
markers in the
patients of RA. Also, to the best of our
knowledge, there is no previous study in which, effect of 12 weeks of yoga
therapy has been studied in the RA patients. Therefore, present study has been
conceived.
C. Expected outcome &
application :
The
expected outcome of the proposed study is the effect of 12 weeks of yoga
therapy on disease activity, body composition, cardiac autonomic functions,
inflammatory and oxidative markers in patients with rheumatoid arthritis
Applicability
The outcome
of the study will be highly useful for the treatment / management of rheumatoid arthritis patients along with the
standard medical treatment
3. Research question(s) : What is the effect of yoga on disease
activity, body composition, cardiac autonomic functions and inflammatory and oxidative markers in patients with rheumatoid arthritis ?
4.
Research hypothesis (es), if any :
Twelve weeks of yoga practice will reduce
the disease activity, inflammation & oxidative stress and
improve the body composition, cardiac autonomic
functions in patients with rheumatoid
arthritis.
5. Aim and objectives:
Primary objective(s) :
1. To
assess the effect of 12 weeks of yoga therapy on disease activity, body
composition, cardiac autonomic functions, inflammatory and oxidative markers in
patients with rheumatoid arthritis.
2. To
assess body composition, cardiac autonomic functions, inflammatory, oxidative
markers and disease activity in patients with
rheumatoid arthritis.
3. To
identify the association of body composition, cardiac autonomic functions, inflammatory, oxidative
markers and disease activity among rheumatoid arthritis patients.
Secondary objective(s)
To assess the effect of yoga
on quality of life by Health
Assessment Questionnaire among the patients
with rheumatoid arthritis.
Relevant references
for the project (in Vancouver style, cited sequentially in the text of
project) : - 1.
Sokka T, Abelson B, Pincus T. Mortality
in rheumatoid arthritis: 2008 update. Clin Exp Rheumatol 2008; 26(5): 35–61.
- 2.
Mutru O, Laakso M, Isomaki H, Koota K.
Ten year mortality and causes of death in patients with rheumatoid arthritis. Br
Med J 1985; 290(6484): 1797-9.
- 3.
Roubenoff R, Roubenoff RA, Ward LM, Holland SM,
Hellman DB. Rheumatoid cachexia: depletion of lean body mass in rheumatoid
arthritis: possible association with tumor necrosis factor. J Rheumatol 1992; 19: 1505–10.
- 4.
Kremers
HM, Nicola PJ, Crowson CS, Ballman KV, Gabriel SE. Prognostic importance of low
body mass index in relation to cardiovascular mortality in rheumatoid
arthritis. Arthritis Rheum 2004; 50: 3450–7.
- 5.
Hauner H. Secretory factors from human adipose
tissue and their functional role. ProcNutrSoc
2005; 64: 163–9.
- 6.
Stojanovich L, Milovanovich B , DeLuka SR,
Popovich-Kuzmanovich D, Bisenich V, Djukanovich B et al. Cardiovascular
autonomic dysfunction in systemic lupus, rheumatoid arthritis, primary Sjogren
syndrome and other autoimmune diseases. Lupus
2007; 16: 181-5.
- 7.
Yadav RK, Gupta R, Deepak KK. A pilot study on short
term heart rate variability & its correlation with disease activity in
Indian patients with rheumatoid arthritis. Indian J Med Res 2012; 136: 593–8.
- 8.
Manzi S, Wasko MC. Inflammation-mediated rheumatic
diseases and atherosclerosis. Ann
Rheum Dis 2000; 59: 321–5.
- 9. Evans S, Moieni M, Lung K et al. Impact of Iyengar yoga on quality of
life in young women with rheumatoid arthritis. Clin J Pain 2013; 29(11): 988-97.
- 10. Singh VK, Bhandari RB, Rana BB. Effect of yogic package on rheumatoid
arthritis. Indian J Physiol Pharmacol 2011; 55: 329-35.
- 11.
Williams K, Steinberg L, Petronis J. Therapeutic
Application of Iyengar Yoga for Healing Chronic Low Back Pain. Int J Yoga 2003; 13: 55-67.
- 12.
Balaji PA, Varne SR, Ali SS. Physiological effects
of yogic practices and transcendental
meditation in health and disease. N Am
J Med Sci 2012; 4: 442-8.
- 13. Badsha H, Chhabra V, Leibman C et al. The
benefits of yoga for rheumatoid arthritis: results of a preliminary, structured
8-week program. Rheumatol Int 2009; 29:
1417-21.
|