Rheumatic DiseaseNCT01755832
Heated Pool Exercise Groups for Patients With Rheumatic Diseases
An observational study of Rheumatic Disease, run by National Resource Center for Rehabilitation in Rheumatology at 1 site in Norway.
Trial summary
The purpose of this study is to investigate the effects of heated pool group exercises for patients with inflammatory rheumatic diseases with regard to symptoms (pain, fatigue, stiffness and ability to carry out daily activities). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatic Disease
- What is being tested?
- Pool exercise
- Type of treatment
- Surgery or procedure
- How many people
- 36 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2012to Jan 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with inflammatory rheumatic joint diseases with a medical referral to group exercises in heated pool.
Who may be able to join
- Referral from a medical doctor to group exercises in heated pool
- Inflammatory rheumatic joint disease
- > 18 years
- Stable disease
- Mobile phone owner
- Understand and use text messages on mobile phones
Who cannot join
- Independent living
- Joint surgery previous to the study start
Trial locations and contacts
1 site in 1 country.
Norway1 site
National resource center for rehabilitation in rheumatology
Oslo, 0319
About this study
Official title: Better Everyday-life With Heated Pool Exercise Groups for Patients With Inflammatory Rheumatic Diseases
The purpose of this study is to investigate the effects of heated pool group exercises for patients with inflammatory rheumatic diseases with regard to symptoms (pain, fatigue, stiffness and ability to carry out daily activities).
Read the detailed description
The patients receive text messages on mobile phones twice a week for circa 40 weeks. The text messages ask for pain, fatigue, stiffness and ability to carry out everyday activities. The patients should respond with a number from 0 to 10, where 0 is no symptoms/no hindering of activity and 10 is worst symptoms/worst hindering of activity.
- Conditions
- Rheumatic Disease
- Being tested
- Pool exercise
- Keywords
- inflammatory rheumatic joint disease, text message, > 18 years, Norwegian speaking
- Medical subject headings
- Rheumatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pool exerciseProcedure or surgery
Group exercise in heated pool one hour per week for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Pool exercise group | Patients with inflammatory rheumatic disease Receives: Procedure: Pool exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Activity
How much do your health problems affect your ability to conduct daily activities? The outcome is assessed on a ten-point rating scale ranging from zero to ten with "0" representing "no affect" and "10" representing "extreme affect".
Measured: 40 weeks
Pain
How much pain do you have at present? The outcome is measured on a ten-point numeric rating scale (NRS) ranging from zero to ten with "0" representing "no pain" and "10" representing "extreme pain".
Measured: 40 weeks
Fatigue
How much fatigue do you have at present? The outcome is assesses on a ten-point rating scale ranging from zero to ten with "0" representing "no fatigue" and "10" representing "extreme fatigue"
Measured: 40 weeks
Stiffness
How much stiffness do you have at present? The outcome is assessed on a ten-point numeric rating scale with "0" representing "no stiffness" and "10" representing "extreme stiffness".
Measured: 40 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2012 (estimated)
- Study startSep 2012
- Primary completionOct 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatic DiseaseStudies 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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Resource Center for Rehabilitation in Rheumatology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne Christie, National Resource Center for Rehabilitation in Rheumatology
- Investigators
- Anne Christie, Ph.D., Principal investigator, National resource centre for rehabilitation in rheumatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01755832
- Sponsor's protocol ID
- 2011/1654
- Other IDs
- NRF2012, OSL2012
- Status last verified
- Dec 2012
- First submitted
- 15 Dec 2012
- Last updated
- 9 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Better Everyday-life With Heated Pool Exercise Groups for Patients With Inflammatory Rheumatic Diseases
- ClinicalTrials.gov ID
- NCT01755832
- Acronym / sponsor ID
- 2011/1654
- Conditions
- Rheumatic Disease
- Keywords
- inflammatory rheumatic joint disease, text message, > 18 years, Norwegian speaking
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- National Resource Center for Rehabilitation in RheumatologyUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Oct 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 24 Dec 2012 (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.
The purpose of this study is to investigate the effects of heated pool group exercises for patients with inflammatory rheumatic diseases with regard to symptoms (pain, fatigue, stiffness and ability to carry out daily activities).
Detailed description
The patients receive text messages on mobile phones twice a week for circa 40 weeks. The text messages ask for pain, fatigue, stiffness and ability to carry out everyday activities. The patients should respond with a number from 0 to 10, where 0 is no symptoms/no hindering of activity and 10 is worst symptoms/worst hindering of activity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pool exercise group | – | Procedure: Pool exercisePatients with inflammatory rheumatic disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with inflammatory rheumatic joint diseases with a medical referral to group exercises in heated pool.
Key inclusion criteria (6 listed)
- Referral from a medical doctor to group exercises in heated pool
- Inflammatory rheumatic joint disease
- > 18 years
- Stable disease
- Mobile phone owner
Key exclusion criteria (2 listed)
- Independent living
- Joint surgery previous to the study start
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pool exerciseGroup exercise in heated pool one hour per week for 12 weeks. | Procedure or surgery | Pool exercise group |
Primary outcome
Activity
Time frame: 40 weeks
How much do your health problems affect your ability to conduct daily activities? The outcome is assessed on a ten-point rating scale ranging from zero to ten with "0" representing "no affect" and "10" representing "extreme affect".
Pain
Time frame: 40 weeks
How much pain do you have at present? The outcome is measured on a ten-point numeric rating scale (NRS) ranging from zero to ten with "0" representing "no pain" and "10" representing "extreme pain".
Fatigue
Time frame: 40 weeks
How much fatigue do you have at present? The outcome is assesses on a ten-point rating scale ranging from zero to ten with "0" representing "no fatigue" and "10" representing "extreme fatigue"
Stiffness
Time frame: 40 weeks
How much stiffness do you have at present? The outcome is assessed on a ten-point numeric rating scale with "0" representing "no stiffness" and "10" representing "extreme stiffness".
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2015.
- Full text articleLink provided by the sponsor.
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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.
Anne Christie, Ph.D. principal investigator
National resource centre for rehabilitation in rheumatology
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 Rheumatic Disease, run by National Resource Center for Rehabilitation in Rheumatology at 1 site in Norway.
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 6 inclusion and 2 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: finished, as of the sponsor's last update on 9 Jan 2015. 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 Norway. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Activity (time frame: 40 weeks). The study lists 4 primary outcomes in all. 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 9 Jan 2015.