Please select the eligibility criteria that correspond 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: 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).
B: Inclusion Criteria:

1. Type 2 diabetes
2. Age 40 to 80 years at screening
3. BMI \>27\<40 kg/m2
4. Sedentary for at least 6 months
5. Treated with prescribed diet and/or OHA and insulin
6. Able to walk for 1.6 Km unaided.
7. Eligible after positive outcome of cardiac evaluation

Exclusion Criteria:

1. All patients with a history of central nervous dysfunction such as hemiparesis, myelopathies, cerebral ataxia, significant musculoskeletal deformities such as an amputation, dysmetria or scoliosis, patients with movement abnormalities or arthritis limited by pain when exercising
2. A history of clinical evidence of severe cardiovascular disease which may limit or be a contraindication for exercise
3. Clinical evidence of vestibular dysfunction
4. Angina and related symptoms
5. Postural hypotension defined as a fall in arterial blood pressure when changing position of \>20 mmHg (systole) or \>10 mmHg (diastole
6. History of plantar sores
C: Inclusion Criteria:

Community-dwelling older persons aged 65 or above.

Able to walk without help of another person during 2 minutes, and without major physical limitations, defined as a score on the Short Physical Performance Battery (Guralnik et al., 1995) of 4 or above. The use of an assistive device will be permitted.

Insufficiently active and/or Self-report sitting too much during a usual day. Answer yes to the following question: 'Do you perform regular physical activity (PA) at least 30 minutes five or more days of the week (please only refer to physical activity that makes the participant run out of breath while doing it or it doesn't allow him/her to maintain a conversation while doing the activity (do not count regular walking)?'

And/or answer yes to question: 'For most days, do you feel you sit for too long (6-8 hours or more a day)? Some examples might include when watching TV, working the computer / laptop or when doing sitting-based hobbies such as sewing'.

Exclusion Criteria:

Dementia assessed with the six-Item Screener. Participants with three or more errors should be excluded.

Unstable medical conditions (e.g. elevated blood pressure after medication) or with symptomatic cardiovascular disease.

Any medical condition which may interfere with the study design (e.g. end-stage disease).

Refuse to wear an accelerometer (primary outcome)

Unable to attend during the study period (80% of the total sessions).

Had participated in an ERS in the 6 months prior the study.
D: Inclusion Criteria:

* Obese subjects (IMC ≥ 27.5 to \<40), classified as sedentary according to the short physical activity questionnaire validated in the EVIDENT II study.

Exclusion Criteria:

* Older than 65 years are excluded, due to difficulties in the use of ICTs.
* Advanced respiratory, renal or liver disease.
* Several mental illness
* Coronary or cerebrovascular atherosclerotic disease, grade II or higher NYHA heart failure.
* Moderate or severe COPD
* Muscular-skeletal pathology that inhibit mobility
* Subjects who can not exercise or follow a hypocaloric diet.
* Oncologic disease in treatment diagnosed in the last 5 years.
* Terminal situation
* Pregnancy
* Bariatric surgery
* Those with any other circumstance that the investigators consider could interfere with the study procedures

Answer: A