Rheumatoid ArthritisNCT01071863
Association of Fear of Falling and Physical Activity in Rheumatoid Arthritis Comparison Before and After Biological Therapy
An observational study of Rheumatoid Arthritis, run by Newcastle-upon-Tyne Hospitals NHS Trust at 1 site in United Kingdom.
Trial 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 Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2010to Oct 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 20 patients with Rheumatoid arthritis refered for biological treatment 20 control subjects matched for age and sex
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Newcastle upon Tyne NHS F Trust
Newcastle, UK, NE7 7DN
Peta S Heslop, RN MSc, 0191 2336161 ext. 31327, peta.heslop@nuth.nhs.uk
David J Walker, MD
About this study
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
Read the 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.
- Conditions
- Rheumatoid Arthritis
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2010 (estimated)
- Study startMar 2010
- Primary completionOct 2010 (estimated)
- Study completionOct 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Newcastle-upon-Tyne Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Investigators
- David J Walker, MD, Principal investigator, Newcastle upon Tyne NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01071863
- Sponsor's protocol ID
- RA-FOF-ACT-2010
- Status last verified
- Feb 2010
- First submitted
- 18 Feb 2010
- Last updated
- 22 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Fear of Falling and Physical Activity in Rheumatoid Arthritis Comparison Before and After Biological Therapy
- ClinicalTrials.gov ID
- NCT01071863
- Acronym / sponsor ID
- RA-FOF-ACT-2010
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Newcastle-upon-Tyne Hospitals NHS TrustUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Oct 2010 (estimated)
- Study completion
- Oct 2010 (estimated)
- First posted
- 19 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 20 patients with Rheumatoid arthritis refered for biological treatment 20 control subjects matched for age and sex
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To identify the prevalence and severity of the fear of falling in a rheumatoid population
1 secondary outcome
To explore the effect the treatment with biological agents has on fear of falling and physical activity in a rheumatoid population
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David J Walker, MD principal investigator
Newcastle upon Tyne NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by Newcastle-upon-Tyne Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peta s heslop, RN Msc (0191 2336161 ext. 31327, pet.heslop@nuth.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To identify the prevalence and severity of the fear of falling in a rheumatoid population. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2010.