Reduction of Daily Sitting Time in Patients With Rheumatoid Arthritis. A Randomized Controlled Trial.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 150
- Locations
- 2
- Primary Endpoint
- Changes in daily sitting time in hours and minutes
Study Overview
Brief Summary
Background:
In recent years there has been a growing interest in sedentary behaviour defined as activities performed in sitting or lying position during waking hours. Sedentary behaviour has been recognised as an independent risk factor for cardiovascular diseases and mortality. A few intervention studies in older sedentary people and in overweight or obese adults have demonstrated, that daily sitting time can be reduced through behavioural intervention.
Patients with rheumatoid arthritis (RA) have an increased risk for cardiovascular diseases, partly caused by the rheumatic disease itself but also because of physical inactivity. Studies have documented a positive effect of increasing physical activity on pain and physical functioning in patients with RA. However, the studies also show, that the patients find it difficult to maintain the increased physical activity levels over time. Previous studies suggest that in promoting health among patients with mobility disability should not solely focus on increasing moderate to vigorous physical activity but also target reduction of sedentary behaviour and increase of light physical activity. In the present study we will focus on reduction of daily sitting time and increase of light physical activity as this approach may prove more feasible for patients with RA.
Objectives and hypothesises:
We hypothesise, that sedentary behaviour can be reduced in patients with RA through a behavioural lifestyle change. In addition, we hypothesize, that reduction of daily sitting time can have a positive effect on symptoms and general health in patients with RA.
The primary objective of the present intervention study is to investigate the effect of a motivational counselling intervention on daily sitting time in adult men and women with RA. Furthermore we want to investigate whether a reduction in daily sitting time is related to reduction in pain and fatigue, reduced weight and waist circumference and improved quality of life, physical function and improved cardiovascular biomarker levels (cholesterol and blood pressure).
Study setting and allocation:
In total, 150 participants will be recruited from the rheumatology outpatient clinic at Glostrup University Hospital, Denmark. The participants will be allocated to either an intervention group (75) or a control group (75).
Intervention:
The intervention aims to support and strengthen the participants' belief in their own ability to reduce their daily sitting time. The intervention will include 1) three individual motivational counselling sessions (60-90 minutes), conducted by one of four project nurses in combination with 2)Individual Short Text Messages (SMS). The counselling sessions will focus on information about the positive health effects of reducing daily sitting time and the participants' own goals of reducing their sitting time. Based on the goals the participants will receive weekly SMS reminders.
Data collection:
Measurements on all participants will be done four times during 22 months; 1) at baseline, 2) 16 weeks after start (by the end of the intervention), 3) six months after end of intervention and 4) 18 months after end of intervention. At each of the four visits the participants fill in questionnaires regarding demographics, lifestyle, daily sitting time, physical activity, physical function, pain , fatigue and quality of life. Furthermore, two occupational therapists will measure the participants' blood pressure, height, weight and waist circumference. At the same time a little monitor will be placed on the participants' thigh, which they will carry for seven days. The monitor measures the participants' physical activity level. The four measurements also include a blood sample from the participants in order to measure cholesterol levels.
Detailed Description
Background and rationale:
Physical inactivity is an established risk factor for chronic disease and premature death. In addition to physical inactivity sedentary behaviour has been recognised as a distinct and independent risk factor for cardio metabolic morbidity and mortality in an increasing number of population-based observational studies. Patients with rheumatoid arthritis (RA) have an increased risk for cardio metabolic disease and pre-mature death. The increased risk is, partly caused by the chronic autoimmune rheumatic disease itself and partly to traditional risk factors e.g. hyperlipidemia and hypertension, but can also be attributed to physical inactivity. In Denmark 67 % of patients with RA do not comply with public health recommendations for daily moderate and vigorous physical activity (MVPA), and equivalent proportions are found in Germany (68 %) and the United Kingdom (67 %). Everyday life of patients suffering from RA is periodically influenced by high disease activity (flares) with symptoms such as swelling and stiffness of the joints accompanied by intense pain, leading to severe limitations in physical functioning and potential progressive joint destruction. Intervention studies in patients with RA have documented a positive effect of exercise on pain and physical functioning. However, studies have also demonstrated that exercise and increased activity levels are difficult to maintain over time. Pain has been identified as a main barrier against adaptation and maintenance of a physically activity lifestyle.
Sedentary behaviour can be defined as low metabolic cost activities performed in sitting or reclining positions during waking hours. Sedentary behaviour has become increasingly prevalent in modern society, and recent population studies using self-reported questionnaires estimate daily sitting time of 8-9 hours per day, corresponding to 50-60 % of waking hours in adult general population samples. Likewise, an American population-based study among 4.757 adults, found an objectively measured daily sitting time of 8.44 hours. A few studies have monitored objectively measured sitting time in patients with chronic disease and mobility disability, and these studies generally find that higher proportions of the day are spent sitting among people with various types of mobility disability, i.e. stroke (86-88 % of waking hours), multiple sclerosis (75-85 % of waking hours) and Parkinson's disease (76 % of waking hours). However, to our knowledge no studies have reported objectively measured sitting time in patients with RA. A review from 2011 suggests that aiming to increase PA levels among patients with mobility disability should not solely focus on increasing MVPA, but should also target reduction of sedentary time and increase of light intensity activity, as this approach may prove feasible for improving health and well-being among sedentary patients with chronic disease and mobility limitation.
A few short term intervention studies in older people, and in overweight or obese adults have demonstrated that sedentary behaviour can be reduced through behavioural intervention and that physical activity energy expenditure may be increased by reduction of TV-viewing time. All studies applied objective measures of sitting time.
Objectives:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosed with RA (defined by the American College Rheumatology (ACR) criteria)
- •Over the age of 18 years
- •Self-reported sitting time for five hours or more per day (measured by Physical Activity Scale, PAS 2.1)
- •Physical function score <2.5 (measured by Health Assessment Questionnaire, HAQ)
- •Informed consent
- •Understand and speak Danish
- •Access to mobile phone.
Exclusion Criteria
- •Severe physical disabilities (HAQ-score > 2.5) which would prevent them from reducing daily sitting time (e.g. use of wheelchair);
- •Pregnancy
- •Vigorous physical activity for more than eight hours a week (measured by PAS 2,1).
Outcomes
Primary Outcomes
Changes in daily sitting time in hours and minutes
Time Frame: Baseline, 4 months, 10 months and 22 months
Changes in objectively measured daily sitting time will be obtained using an ActivPAL® Activity Monitor. This is a small and light uniaxial accelerometer-based device that is worn anteriorly on the upper right thigh and kept in place by waterproof dressing and adhesive tape. The monitor uses accelerometer-derived information about thigh position to estimate time spent in different body positions (i.e. sitting/lying, standing and walking). The activPAL monitor is currently considered the best choice for objective measurement of sitting/lying. Changes in self-reported sitting time at work and during leisure time will be measured by the Physical Activity Scale 2.1 (PAS 2.1), a modified version of the original PAS questionnaire, which has previously been validated against accelerometry, PA logs and maximum oxygen uptake. Respondents are asked to specify number of hours and minutes on an average 24-hour day spent on sitting at work and during leisure time.
Secondary Outcomes
- Fatigue(Baseline, 4 months, 10 months and 22 months)
- Physical Function(Baseline, 4 months, 10 months and 22 months)
- Blood pressure(Baseline, 4 months, 10 months and 22 months)
- Pain(Baseline, 4 months, 10 months and 22 months)
- Self-efficacy(Baseline, 4 months, 10 months and 22 months)
- Serum Lipids(Baseline, 4 months, 10 months and 22 months)
- Health Related Quality of Life (HR-QOL)(Baseline, 4 months, 10 months and 22 months)
- Anthropometric measures(Baseline, 4 months, 10 months and 22 months)
Investigators
Tanja Thomsen
PhD-student
Glostrup University Hospital, Copenhagen