Rheumatoid Arthritis Clinical Trial
Official title:
Effectiveness of Community Based Physical Activity on Step Count and Sedentary Behaviour in Patients With Rheumatoid Arthritis Within the First Five Years of Diagnosis
The overall aim of this randomized control trial study is to investigate the effectiveness of a six-month, community based, pedometer supported, walking programme, along with an education programme incorporating behavioural change techniques on steps count and sedentary time, disease activity, functional capacity and cardiovascular risk of people within the first five years of being diagnosed with RA.
All patients attending the rheumatology clinics at Gartnavel General Hospital, Glasgow Royal
Infirmary and Stobhill Hospital who have received a diagnosis of rheumatoid arthritis,
according to the American College of Rheumatology revised Criteria (ACR) 1987/European
League Against Rheumatism (EULAR) 2010 (Amett et al, 1988; Aletaha et al, 2010) within the
first five years of disease will be eligible to take part. Patients will be informed of the
study at their routine clinical appointments and will be given study information sheets, in
order to inform and help them decide whether they would like to enroll in the study. If the
patient is willing to take part in the study, they will contact the researcher by phone and
a suitable date/time for assessment will be arranged and confirmed by letter. For further
enquiries, patients can telephone the researcher via contact details on the study
information sheet. All participants will be informed that they are free to withdraw from the
study at any time. On the initial assessment day, the participant will have the opportunity
to ask further questions before being asked to sign a consent form for the study. All
participants who agree to take part will be required to consent to being randomized to
either the physical activity (Walking) group; Group (1) or Comparison group; Group (2).
A pedometer will be given to each person in the intervention group at the first education
session.Participants will be encouraged to use the pedometer for a 6 month period, and will
be instructed to wear it on the waist band above the hip during all waking hours and daily
physical activity. The only exceptions would be when they are immersed in water (bathing or
swimming) or in bed at night. They will also be instructed to reset the pedometer to zero at
the beginning of each day and remove it at the end of the day. They will be given physical
activity diary in which they will be asked to record: the time the pedometer was attached,
removed and total number of steps displayed on the pedometer at the end of each day.During
the fourth education session, i.e. one month after beginning the programme, participants
will be asked to add strength exercises to their programme. The strength exercises will be
performed at home and will be encouraged to keep a record in the physical activity diary:
time, duration and any barriers to performing the exercise and how these were overcome.
According to the United Kingdom physical activity guidelines and Start Active, Stay Active
2011, strength exercises for the major muscles of the lower limb, trunk and upper limb will
be performed at home twice a week 8-12 repetitions of each exercise.
At the end of the study participants within the intervention group will keep the pedometer,
as thanks for enrolling in this study.
Participants will attend six weekly sessions in small groups of up to six people; the
content of the sessions will be based on educational cognitive behavioural programme
development, which will allow participants to challenge their way of thinking, and change
negative coping skills, cognition and emotions. Each session will last approximately one
hour, will be interactive, and will take place in the hospital. During the one hour
education session,topics will be discussed as interactive session, with the physiotherapist
and participants. Visit 1 will be a measurement session, the education sessions will start
at visit 2, and all participants in the intervention group will receive a pedometer and
information regarding how the pedometer should be used and physical activity diary which
they will start to use.
In addition, participants will receive education material in the first education session
visit 2, which will consist of written information describing the importance of both walking
and a healthy diet for health benefits and the reduction of cardiovascular risk and other
co- morbidities of RA. Education sessions and the written material will be in large text and
be suitable for any reading age.
The intervention group will receive two booster sessions, after 3 and 6 months to provide
support to the participants First session interactive discussion on cardiovascular disease
(CVD), Rheumatoid arthritis, Risk of CVD in Rheumatoid Arthritis, the importance of physical
activity, Goal setting, instruction and practice on how to use pedometer.
second session Group discussion regarding exercise and physical activity and self-monitoring
of behaviour, barriers to physical activity (Problem solving), advice, discussion on the
importance of social support.
session 3 Relapse prevention, Control over CVD via lifestyle behaviour. session 4 Relevance
and importance of strength training and opportunity to practice exercises.
session 5 Interactive discussion regarding healthy diet, strategies to enhance perceived
control.
session 6 Motivation, Social facilitation, Action planning for the next 6 weeks.
First booster session Discuss any barriers, encouragement and motivation of the participants
to continue in this programme.
Second Booster session Discuss any barriers, encouragement and motivation of the
participants to continue in this programme.
Comparison Group The comparison group will be assessed at baseline (visit1), , after they
have agreed to enroll in this study. The assessment will take approximately one hour;
participants randomly allocated to the comparison group will receive one education session
(visit 2) regarding the importance of exercise and healthy diet and will be given education
material similar to intervention group and encouraged to read it. The comparison group will
also be assessed at 3, 6 and 12 months (end of the study). On completion of the study all
participants in the comparison group will be given a pedometer, activity diaries and advice
on how to use them.
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