Association of Fear of Falling and Physical Activity in Rheumatoid Arthritis Comparison Before and After Biological Therapy

NCT01071863 | Unknown

• 1 other identifier: RA-FOF-ACT-2010
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objective: To identify the prevalence and severity of the fear of falling in a rheumatoid population Secondary Objectives: To explore the effect the treatment with biological agents has on fear of falling and physical activity in a rheumatoid population

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• To identify the prevalence and severity of the fear of falling in a rheumatoid population

Secondary Outcomes (1)

• To explore the effect the treatment with biological agents has on fear of falling and physical activity in a rheumatoid population

Study Arms (2)

Rheumatoid Arthritis (RA) Patient Group

Patients with RA who have been refered for biological drug treatment

Control Group

20 people of same age and sex as the RA patient cohort

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

20 patients with Rheumatoid arthritis refered for biological treatment 20 control subjects matched for age and sex

You may qualify if:

• Male and female subjects
• Subjects with a clinical diagnosis of Rheumatoid Arthritis who have been referred for a biologic treatment
• Subjects who are willing to complete the questionnaires and wear the Numact activity monitor
• Written informed consent
• Male and female subjects
• Age and sex matched to RA population (any appropriate sibling will be invited possibly siblings)
• Subjects who are willing to complete the questionnaires and wear the Numact activity monitor
• Written informed consent

You may not qualify if:

• Diagnosis or evidence of any other physically limiting condition
• Subjects who have received an intramuscular steroid injection within 2 months of study entry or in whom such treatment is planned within the study period
• Subjects scheduled for elective surgery of the disease site or any other elective major surgery which would fall within the study period
• Subjects who currently abuse alcohol or drugs, or have a recent history of alcohol or drug abuse, or who in the Investigator's opinion, have previously demonstrated drug-seeking behavior
• Subjects who are currently participating in another clinical research study involving a new chemical entity or who have participated in a clinical study within the previous 30 days
• Subjects who the Investigator believes are unsuitable for the study
• Diagnosis or evidence of any physically limiting condition
• Subjects who currently abuse alcohol or drugs, or have a recent history of alcohol or drug abuse, or who in the Investigator's opinion, have previously demonstrated drug-seeking behavior
• Subjects who the Investigator believes are unsuitable for the study

Sponsors & Collaborators

• Newcastle-upon-Tyne Hospitals NHS Trust: lead

Study Sites (1)

Newcastle upon Tyne NHS F Trust

Newcastle, UK, NE7 7DN, United Kingdom

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

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

Study Officials

• David J Walker, MD

  Newcastle upon Tyne NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peta s heslop, RN Msc

CONTACT

0191 2336161; pet.heslop@nuth.nhs.uk

Javier J Perez, Dr

CONTACT

0191 2336161; javier.perez@nuth.nhs.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 18, 2010
• First Posted: February 19, 2010
• Study Start: March 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: February 22, 2010

Record last verified: 2010-02

Locations

GB (1)