Reduction of Daily Sitting Time in Patients With Rheumatoid Arthritis

NCT01969604 | Completed DMC

• 1 other identifier: JR-Sedentary Behaviour
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis; Sedentary Behaviour; Motivational Counselling; Short Text Message Service; Fatigue; Pain; Self-efficacy; ActivPAL

Outcome Measures

Primary Outcomes (1)

• Changes in daily sitting time in hours and minutes

  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.

  Baseline, 4 months, 10 months and 22 months

Secondary Outcomes (8)

• Fatigue

  Baseline, 4 months, 10 months and 22 months

• Pain

  Baseline, 4 months, 10 months and 22 months

• Physical Function

  Baseline, 4 months, 10 months and 22 months

• Health Related Quality of Life (HR-QOL)

  Baseline, 4 months, 10 months and 22 months

• Self-efficacy

  Baseline, 4 months, 10 months and 22 months

Other Outcomes (1)

• Cost data

  Baseline, 22 months

Study Arms (2)

Motivational lifestyle counselling

EXPERIMENTAL

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

Control Group

NO INTERVENTION

A control group will be encouraged to maintain their usual lifestyle during the 16-week intervention period.

Interventions

Motivational Lifestyle Counselling BEHAVIORAL

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.

Motivational lifestyle counselling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Glostrup University Hospital, Copenhagen: lead

Study Sites (1)

Research Unit of Nursing and Health Science, Glostrup University Hospital, Copenhagen, Denmark

Copenhagen, Glostrup, 2600, Denmark

Location

Related Publications (5)

• Sorensen J, Esbensen BA, Aadahl M, Hetland ML, Thomsen T. Cost-effectiveness of motivational counselling and text reminders in patients with rheumatoid arthritis: results based on a randomised clinical trial. RMD Open. 2022 Jul;8(2):e002304. doi: 10.1136/rmdopen-2022-002304.

  PMID: 35853676 DERIVED

• Thomsen T, Aadahl M, Beyer N, Hetland ML, Loppenthin KB, Midtgaard J, Christensen R, Nielsen SM, Ostergaard M, Jennum P, Esbensen BA. Sustained Long-Term Efficacy of Motivational Counseling and Text Message Reminders on Daily Sitting Time in Patients With Rheumatoid Arthritis: Long-Term Follow-up of a Randomized, Parallel-Group Trial. Arthritis Care Res (Hoboken). 2020 Nov;72(11):1560-1570. doi: 10.1002/acr.24060.

  PMID: 31507095 DERIVED

• Thomsen T, Aadahl M, Beyer N, Hetland ML, Loppenthin K, Midtgaard J, Christensen R, Ostergaard M, Jennum PJ, Esbensen BA. The efficacy of motivational counselling and SMS reminders on daily sitting time in patients with rheumatoid arthritis: a randomised controlled trial. Ann Rheum Dis. 2017 Sep;76(9):1603-1606. doi: 10.1136/annrheumdis-2016-210953. Epub 2017 Jun 5.

  PMID: 28584189 DERIVED

• Thomsen T, Aadahl M, Beyer N, Hetland ML, Loppenthin K, Midtgaard J, Christensen R, Esbensen BA. Motivational counselling and SMS-reminders for reduction of daily sitting time in patients with rheumatoid arthritis: a descriptive randomised controlled feasibility study. BMC Musculoskelet Disord. 2016 Oct 18;17(1):434. doi: 10.1186/s12891-016-1266-6.

  PMID: 27756265 DERIVED

• Esbensen BA, Thomsen T, Hetland ML, Beyer N, Midtgaard J, Loppenthin K, Jennum P, Ostergaard M, Sorensen J, Christensen R, Aadahl M. The efficacy of motivational counseling and SMS-reminders on daily sitting time in patients with rheumatoid arthritis: protocol for a randomized controlled trial. Trials. 2015 Jan 27;16:23. doi: 10.1186/s13063-014-0540-x.

  PMID: 25623388 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid; Fatigue; Pain

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations

Study Officials

• Bente Al Esbensen, Research Manager

  Research Unit of Nursing and Health Science, Glostrup University Hospital, Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD-student

Study Record Dates

• First Submitted: October 17, 2013
• First Posted: October 25, 2013
• Study Start: April 1, 2013
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: June 5, 2017

Record last verified: 2017-06

Locations

DK (1)