Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by Newcastle-upon-Tyne Hospitals NHS Trust.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Newcastle-upon-Tyne Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT01071863
First received: February 18, 2010
Last updated: February 19, 2010
Last verified: February 2010

February 18, 2010
February 19, 2010
March 2010
October 2010   (final data collection date for primary outcome measure)
To identify the prevalence and severity of the fear of falling in a rheumatoid population [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01071863 on ClinicalTrials.gov Archive Site
To explore the effect the treatment with biological agents has on fear of falling and physical activity in a rheumatoid population [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Association of Fear of Falling and Physical Activity in Rheumatoid Arthritis Comparison Before and After Biological Therapy
Association of Fear of Falling and Physical Activity in Rheumatoid Arthritis Comparison Before and After Biological Therapy

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

The study will be an open, observational study to determine the prevalence of fear of falling in a rheumatoid population with severe disease being considered for biological therapy; this will be compared with physical activity levels at baseline and the change in these level pre and post treatment with biologic therapy. An age and sex matched control group will also be studied to allow inference to be drawn from the self reported 'fear of falling' and the objective activity levels of the RA population.

The study will consist of two visits: screening/baseline, and a 12 week follow up visit. It will be an observational study of the effects of the planned treatment regime via the NHS pathway. The subjects who are eligible to enter in the study will receive his/her normal treatment prescribed and be at the referral phase for biological treatment. The control group will continue on any existing treatments but will not have any reported physical limitations.

At the screening/baseline visit the self completion outcome questionnaires will be given to both the patient group and the control group. A disease activity score (aggregate score of RA symptoms - DAS) for the RA population will be calculated by a nurse specialist at the time of referral for the biological agent and again at 12 weeks post treatment, these parameters will not be repeated by the research team but the DAS score will be collected used in the final analysis. In addition, the Numact ambulatory activity recorder - used to assess spontaneous ambulatory activity - will be fitted for a 24hour period. This screening / baseline visit will occur before, but as near as possible to the 1st treatment day of the prescribed biological agent.

Occasionally the recording device may fail due to extraneous factors; in this instance a second recording may be required.

The control group will complete their study participation immediately after the screening / baseline visit.

The participant will then follow the care pathway of their treating physician with no interception by the study team. The 2nd and final study visit will be scheduled for 12 weeks post treatment with the biologic agent.

At 12 weeks a repeat assessment of the screening procedures will be made. Beyond which there will be no further study contact with the patients unless they request further discussion about the study findings. If they request this an appointment will be made at the time of the final study report/write up.

Physical examination could be carried out at any time during the study period if considered appropriate by the physician, however, this is not a predicted study procedure..

Details of any changes in medication and adverse events will be reported by subjects at the final visit, week 12.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

Rheumatoid Arthritis
Not Provided
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
40
October 2010
October 2010   (final data collection date for primary outcome measure)

Inclusion criteria RA population:

  1. Male and female subjects
  2. Subjects with a clinical diagnosis of Rheumatoid Arthritis who have been referred for a biologic treatment
  3. Subjects who are willing to complete the questionnaires and wear the Numact activity monitor
  4. Written informed consent

Inclusion criteria Control group:

  1. Male and female subjects
  2. Age and sex matched to RA population (any appropriate sibling will be invited possibly siblings)
  3. Subjects who are willing to complete the questionnaires and wear the Numact activity monitor
  4. Written informed consent

Exclusion criteria RA Population:

  1. Diagnosis or evidence of any other physically limiting condition
  2. 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
  3. Subjects scheduled for elective surgery of the disease site or any other elective major surgery which would fall within the study period
  4. 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
  5. 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
  6. Subjects who the Investigator believes are unsuitable for the study

Exclusion criteria Control Group:

  1. Diagnosis or evidence of any physically limiting condition
  2. 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
  3. Subjects who the Investigator believes are unsuitable for the study
Both
40 Years to 75 Years
Yes
Contact: Peta s heslop, RN Msc 0191 2336161 ext 31327 pet.heslop@nuth.nhs.uk
Contact: Javier J Perez, Dr 0191 2336161 ext 31157 javier.perez@nuth.nhs.uk
United Kingdom
 
NCT01071863
RA-FOF-ACT-2010
No
Dr David Walker, Newcastle upon Tyne hospitals NHS Foundation Trust
Newcastle-upon-Tyne Hospitals NHS Trust
Not Provided
Principal Investigator: David J Walker, MD Newcastle upon Tyne NHS Foundation Trust
Newcastle-upon-Tyne Hospitals NHS Trust
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP