Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Reduction of Daily Sitting Time in Patients With Rheumatoid Arthritis. A Randomized Controlled Trial.
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.


Options:
A: Arm Label: Motivational lifestyle counselling; Type: EXPERIMENTAL; Interventions: Behavioral: Motivational Lifestyle Counselling | Arm Label: Control Group; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Motivational Lifestyle Counselling; Assigned to Arm(s): Motivational lifestyle counselling
B: Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Exercise; Type: EXPERIMENTAL; Interventions: Behavioral: Theoretical & practical exercise counseling | Intervention Type: BEHAVIORAL; Name: Theoretical & practical exercise counseling; Assigned to Arm(s): Exercise
C: Arm Label: Exercise Referral Scheme (ERS); Type: ACTIVE_COMPARATOR; Interventions: Behavioral: ERS and/or Self-management Strategies | Arm Label: ERS + Self-management Strategies; Type: EXPERIMENTAL; Interventions: Behavioral: ERS and/or Self-management Strategies | Arm Label: Control group; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: ERS and/or Self-management Strategies; Assigned to Arm(s): ERS + Self-management Strategies, Exercise Referral Scheme (ERS)
D: Arm Label: Control: Lifestyle counseling; Type: ACTIVE_COMPARATOR; Interventions: Other: Control: Lifestyle counseling | Arm Label: Intervention group; Type: EXPERIMENTAL; Interventions: Other: Intervention group, Other: Control: Lifestyle counseling | Intervention Type: OTHER; Name: Intervention group; Assigned to Arm(s): Intervention group | Intervention Type: OTHER; Name: Control: Lifestyle counseling; Assigned to Arm(s): Control: Lifestyle counseling, Intervention group

Answer: A