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

February 19, 2010 updated by: Newcastle-upon-Tyne Hospitals NHS Trust

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United Kingdom
    • UK
      • Newcastle, UK, United Kingdom, NE7 7DN
        • Newcastle upon Tyne NHS F Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
To identify the prevalence and severity of the fear of falling in a rheumatoid population

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
To explore the effect the treatment with biological agents has on fear of falling and physical activity in a rheumatoid population

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Newcastle-upon-Tyne Hospitals NHS Trust

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: David J Walker, MD, Newcastle Upon Tyne NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2010

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2010

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 18, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 18, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 19, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 22, 2010

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2010

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RA-FOF-ACT-2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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