Rheumatic DiseasesNCT02430402
Rehabilitation of Young Patients With Rheumatic Diseases in a Warm Climate
A study testing Rehabilitation in warm climate in people with Rheumatic Diseases, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
Young patients with rheumatic diseases have challenges different from older patients due to their life situation. It has been reported that they do not have the same benefit from age non-specific rehabilitation in warm climate. Read more about this study
- Who is it for?
- Ages 20 to 35 years
- Conditions the study is for
- Rheumatic Diseases
- What is being tested?
- Rehabilitation in warm climate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteNorway
- Study dates
- May 2015to Aug 2017
- Phase
- Interventional
- 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 20 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Inflammatory rheumatic disease
- Self reliant in daily life
Who cannot join
- conditions that might influence ability to fly to Spain and participate in rehabilitation in warm climate (Unstable heart disease, Serious lung disease, Chronic open ulcers, Serious mental health conditions, alcohol or drug addiction, Intolerant of sun and heat)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Rehabilitation of Young Patients With Rheumatic Diseases in a Warm Climate. A Pilot Randomised Controlled Trial
Young patients with rheumatic diseases have challenges different from older patients due to their life situation. It has been reported that they do not have the same benefit from age non-specific rehabilitation in warm climate. This trial will test the effect of a specially adapted version of a rehabilitation program delivered in Spain (warm climate) for Norwegian young adults aged 20-35 years.
- Conditions
- Rheumatic Diseases
- Being tested
- Rehabilitation in warm climate
- Keywords
- Climatotherapy
- Medical subject headings
- Rheumatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation in warm climateOther
| Study group | Role | What they receive |
|---|---|---|
| Climate therapy | Experimental | Climate therapy consisting of 3 week stay at rehabilitation facility in Spain Receives: Other: Rehabilitation in warm climate |
| Usual care | No intervention | Usual care provided as needed / agreed between patient and health care providers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coping (Effective Consumer Scale (EC17)
Measured with Effective Consumer Scale (EC17)
Measured: 12 months
30 second sit to stand test
Measured: 12 months
Secondary outcomes (7)
EQ5D
Measured: 12 months
Numerical Rating Scales (NRS) fatigue question
Measured: 12 months
Hannover functional Scale
Measured: 12 months
Coop Wonca
Measured: 12 months
Hopkins Symptom Checklist
Measured: 12 months
Patient Specific Functional scale
Measured: 12 months
Numerical Rating Scales (NRS) pain question
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2015 (estimated)
- Study startMay 2015
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatic DiseasesStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital
- Responsible party
- Sponsor
- Investigators
- Aslak Steinsbekk, PhD, Principal investigator, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02430402
- Sponsor's protocol ID
- 013.5
- Status last verified
- Mar 2020
- First submitted
- 22 Apr 2015
- Last updated
- 20 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nilssen IR, Koksvik HS, Gronning K, Steinsbekk A. Rehabilitation in warm climate for young adults with inflammatory arthritis: A 12-month randomized controlled trial. J Rehabil Med. 2020 Apr 14;52(4):jrm00040. doi: 10.2340/16501977-2666.
PubMed 32179929
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Rehabilitation of Young Patients With Rheumatic Diseases in a Warm Climate. A Pilot Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02430402
- Acronym / sponsor ID
- 013.5
- Conditions
- Rheumatic Diseases
- Keywords
- Climatotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital
- Study start
- May 2015 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 30 Apr 2015 (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.
Young patients with rheumatic diseases have challenges different from older patients due to their life situation. It has been reported that they do not have the same benefit from age non-specific rehabilitation in warm climate. This trial will test the effect of a specially adapted version of a rehabilitation program delivered in Spain (warm climate) for Norwegian young adults aged 20-35 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Climate therapy | Experimental | Other: Rehabilitation in warm climateClimate therapy consisting of 3 week stay at rehabilitation facility in Spain |
| Usual care | No intervention | –Usual care provided as needed / agreed between patient and health care providers |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Inflammatory rheumatic disease
- Self reliant in daily life
Key exclusion criteria (1 listed)
- conditions that might influence ability to fly to Spain and participate in rehabilitation in warm climate (Unstable heart disease, Serious lung disease, Chronic open ulcers, Serious mental health conditions, alcohol or drug addiction, Intolerant of sun and heat)
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 |
|---|---|---|
| Rehabilitation in warm climate | Other | Climate therapy |
Primary outcome
Coping (Effective Consumer Scale (EC17)
Time frame: 12 months
Measured with Effective Consumer Scale (EC17)
30 second sit to stand test
Time frame: 12 months
7 secondary outcomes
EQ5D
Time frame: 12 months
Numerical Rating Scales (NRS) fatigue question
Time frame: 12 months
Hannover functional Scale
Time frame: 12 months
Coop Wonca
Time frame: 12 months
Hopkins Symptom Checklist
Time frame: 12 months
Patient Specific Functional scale
Time frame: 12 months
Numerical Rating Scales (NRS) pain question
Time frame: 12 months
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 20 Mar 2020.
- Results publication: PubMed 32179929Nilssen IR, Koksvik HS, Gronning K, Steinsbekk A. Rehabilitation in warm climate for young adults with inflammatory arthritis: A 12-month randomized controlled trial. J Rehabil Med. 2020 Apr 14;52(4):jrm00040. doi: 10.2340/16501977-2666.
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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.
Aslak Steinsbekk, PhD principal investigator
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation in warm climate in people with Rheumatic Diseases, run by Norwegian University of Science and Technology 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 2 inclusion and 1 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 20 Mar 2020. 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?
Coping (Effective Consumer Scale (EC17) (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02430402, which also lists 1 linked publication.
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 20 Mar 2020.