Reduction of Daily Sitting Time in Patients With Rheumatoid Arthritis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01969604|
Recruitment Status : Completed
First Posted : October 25, 2013
Last Update Posted : June 5, 2017
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).
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.
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.
|Condition or disease||Intervention/treatment||Phase|
|Rheumatoid Arthritis||Behavioral: Motivational Lifestyle Counselling||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Reduction of Daily Sitting Time in Patients With Rheumatoid Arthritis. A Randomized Controlled Trial.|
|Study Start Date :||April 2013|
|Actual Primary Completion Date :||May 2016|
|Actual Study Completion Date :||May 2016|
Experimental: Motivational lifestyle counselling
This arm will include 1) Three individual motivational counselling sessions including handouts of four key messages regarding reduction of daily sitting time in combination with 2) Individual Short Text Message (SMS) reminders.
Behavioral: Motivational Lifestyle Counselling
The intervention will focus on individual goal setting and self-efficacy, where participants describe their everyday life in terms of sitting time and set goals how to reduce their daily sitting time. Project staff will introduce the patients to the possible benefits of reducing their daily sitting time.
The intervention focuses on 4 key messages or themes, which are written in booklets that will be handed to the patients: 1) Reduce daily TV-viewing, 2) Substitute sitting with standing when possible, 3) Break up prolonged sitting and 4) Maximum 30 minutes of sitting.
Based on the patients' own individually goals the patients decide how many weekly SMS reminders they want to receive during the 16-week intervention period.Example:
• Hello X. Raise from your table stand-up and allow gravity to assist your lunch to digest. Bonus: You burn more energy when you stand.
No Intervention: Control Group
A control group will be encouraged to maintain their usual lifestyle during the 16-week intervention period.
- 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.
- Fatigue [ Time Frame: Baseline, 4 months, 10 months and 22 months ]The 20-item Multi-dimensional Fatigue Inventory (MFI 20) will be included to measure fatigue. MFI 20 consists of 20 statements such as "I feel enthusiastic" and classifies fatigues in five dimensions: 1) General fatigue 2) Physical fatigue 3) Mental fatigue 4) Reduced activity 5) Reduced motivation.
- Pain [ Time Frame: Baseline, 4 months, 10 months and 22 months ]The Visual Analogue Scale (VAS) transforms the subjective experience of pain to a measurable size. The participant indicates his or her pain by putting a mark on the line where the ends are marked with "no pain" to "worst imaginable pain".
- Physical Function [ Time Frame: Baseline, 4 months, 10 months and 22 months ]Health Assessment Questionnaire (HAQ) is an instrument that contains 20 questions with four possible answers in eight categories of functions within the ADL (regular daily activities): dressing, rising, eating, walking, personal hygiene, to stretch for something, grab objects and everyday activities. In addition, the HAQ includes VAS scales pain, fatigue and general health.
- Health Related Quality of Life (HR-QOL) [ Time Frame: Baseline, 4 months, 10 months and 22 months ]HR-QOL is assessed with 1) SF-36, which is a generic instrument consisting of 36 items divided into eight scales: physical function, role physical activity limitations, pain, general health, vitality, social function, role emotional activity limitations and mental health and 2) EuroQol (EQ-5D-5L), which is a standardized 5 item-instrument developed in order to provide a simple, generic measure of health for clinical and economic appraisal. The EQ-5D-5 L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.
- Self-efficacy [ Time Frame: Baseline, 4 months, 10 months and 22 months ]The General Self-Efficacy Scale assesses a general sense of perceived self-efficacy with the aim to predict coping with daily hassles and adaptation after experiencing stressful life events. The instrument is a 10-item scale with statements such as "I can usually handle whatever comes my way" and "I am confident that I could deal efficiently with unexpected events". The response format is 'not at all true', 'hardly true', 'moderately true', 'exactly true'. The instrument is translated and validated for Danish conditions.
- Anthropometric measures [ Time Frame: Baseline, 4 months, 10 months and 22 months ]Weight is measured in light clothing without shoes to the nearest 0.1 kg; waist circumference is measured midway between the lower rib margin and the iliac crest to the nearest 0.5 centimetre, without any pressure to the skin and with an unstretched tape meter; hip circumference is measured at the point yielding the maximum circumference over the buttocks to the nearest 0.5 centimetre. The tape should be held in a horizontal plane touching the skin but not indenting the soft tissue. Body mass index (BMI, kg/m2) and waist-hip ratio are calculated.
- Blood pressure [ Time Frame: Baseline, 4 months, 10 months and 22 months ]Blood pressure will be measured three times at the right upper arm (average of the three measurements) with the participant is in a sitting/lying position; rest 5-10 minutes before the measurements.
- Serum Lipids [ Time Frame: Baseline, 4 months, 10 months and 22 months ]Venous blood sample will be drawn (not fasting). Total cholesterol, high-density lipoprotein cholesterol (HDL), and triglycerides will be measured by an enzymatic method on the Vitros 5.1 FS from Ortho Clinical Diagnostics. Low-density lipoprotein cholesterol (LDL) and very low-density lipoprotein cholesterol (VLDL) will be calculated by the following formulae (VLDL=Triglyceride x 0.45; LDL=Total cholesterol - HDL + VLDL). Furthermore, C-reactive protein (CRP) and HbA1c will be measured on Vitros 5.1 FS and G8 HPLC Analyzer from TOSOH.
- Cost data [ Time Frame: Baseline, 22 months ]For the analysis of intervention costs patients-related activities will be registered for each individual patient by the health care providers. In addition, data will be collected on time use related to each activity and relevant unit cost of resources. Other resource use and cost related to health care provisions will be obtained for each individual patient from the national health registries for hospitals, primary care and purchase of prescription medication from primary care pharmacies. These data will be obtained from the National Board of Health.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01969604
|Research Unit of Nursing and Health Science, Glostrup University Hospital, Copenhagen, Denmark|
|Copenhagen, Glostrup, Denmark, 2600|
|Principal Investigator:||Bente Al Esbensen, Research Manager||Research Unit of Nursing and Health Science, Glostrup University Hospital, Copenhagen|