Walk for Rheumatoid Arthritis (WARA Study)

NCT02467205 | Completed DMC

• 1 other identifier: GN14RH210
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rheumatoid Arthritis

Keywords

Physical Activity

Outcome Measures

Primary Outcomes (1)

• Change in Physical activity will be assessed.( ActivPAL monitor and International Physical Activity Questionnaire (IPAQ))

  The measure is a composite. Objectively measured physical activity and sedentary behavior will be assessed using an ActivPAL activity monitor, which measures the posture and classifies daily living activity into periods spent sitting, lying, standing and stepping. An ActivPAL monitor will be used in assessment for 7 consecutive days to monitor individual physical activity, time spent sedentary and will also be used at each follow up assessment. The monitor will be attached to the participant's thigh at each assessment point and, following the seven day period. IPAQ is categorized into low, moderate and high physical activity.

  Baseline, 3, 6 months and one year

Secondary Outcomes (6)

• Change in RA assessment from baseline to end of the study using (Disease activity A simplified Disease Activity Index (SDAI) and Rheumatoid Arthritis Quality of Life (RAQoL))

  baseline, 3, 6 months and one year

• change in RA assessment from baseline to the end of the study Functional ability (Six minute walk test (6MWT),Stanford Health Assessment in functional capacity Questionnaire (HAQ) and Hand grip strength )

  baseline, 3, 6 months and one year

• change in Cardiovascular risk factors(Blood pressure will be measured,blood sample will be taken).Anthropometric variables Body mass index, waist circumference, waist hip ratio and waist height ratio.

  baseline, 3, 6 months and one year

• change in Dietary assessment(Dietary Instrument for Nutrition Education (DINE))

  baseline, 3, 6 months and one year

• Change in Self-efficacy to Regulate Exercise

  baseline, 3, 6 months and one year

Study Arms (2)

Intervention

OTHER

pedometer supported walking and education 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 Educational component; 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, In addition, participants will receive education material in the first education session. The intervention group will receive two booster sessions, after 3 and 6 months.

Other: pedometer supported walking and education

Control

NO INTERVENTION

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.

Interventions

pedometer supported walking and education OTHER

A Physical activity; 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. The strength exercises will be performed at home. Education will incorporate the behavioural change techniques (BCTs) known to be effective in increasing physical activity (Goal setting,Self-monitoring of behaviour,Feedback on outcomes of behaviour,Problem solving,Relapse Prevention (RP) and social support).

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed Rheumatoid Arthritis according to American College of Rheumatology (ACR)/ European League Against Rheumatism criteria (EULAR) 2010.
• Diagnosed within the first five years of disease.
• Willing and able to give written informed consent.
• Age 18 years and over.

You may not qualify if:

• Patients will be excluded, if they suffer from severe hypertension, joint replacement in the previous 6 months, unstable cardiac conditions and other serious pathology which would affect their ability to take part in physical activity such as uncontrolled diabetes.
• Pregnancy.
• Unable to understand written and spoken English.
• Cognitive impairment determined by the clinical judgment of the researcher.

Sponsors & Collaborators

• University of Glasgow: lead

Study Sites (1)

Western Infimary

Glasgow, Glasgow, UK, G11 6NT, United Kingdom

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid; Motor Activity

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Lorna Paul, PhD

  University of Glasgow

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student and chief investigator

Study Record Dates

• First Submitted: June 3, 2015
• First Posted: June 9, 2015
• Study Start: November 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: April 1, 2016
• Last Updated: May 3, 2017

Record last verified: 2017-05

Locations

GB (1)