Back to resultsRehabilitation of Young Patients With Rheumatic Diseases in a Warm Climate
Primary Purpose
Rheumatic Diseases
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Rehabilitation in warm climate
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatic Diseases focused on measuring Climatotherapy
Eligibility Criteria
Inclusion Criteria:
- Inflammatory rheumatic disease
- Self reliant in daily life
Exclusion Criteria:
- 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)
Sites / Locations
- Institute for Social Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Climate therapy
Usual care
Arm Description
Climate therapy consisting of 3 week stay at rehabilitation facility in Spain
Usual care provided as needed / agreed between patient and health care providers
Outcomes
Primary Outcome Measures
Coping (Effective Consumer Scale (EC17)
Measured with Effective Consumer Scale (EC17)
30 second sit to stand test
Secondary Outcome Measures
EQ5D
Numerical Rating Scales (NRS) fatigue question
Hannover functional Scale
Coop Wonca
Hopkins Symptom Checklist
Patient Specific Functional scale
Numerical Rating Scales (NRS) pain question
Full Information
NCT ID
NCT02430402
First Posted
April 22, 2015
Last Updated
March 18, 2020
Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02430402
Brief Title
Rehabilitation of Young Patients With Rheumatic Diseases in a Warm Climate
Official Title
Effect of Rehabilitation of Young Patients With Rheumatic Diseases in a Warm Climate. A Pilot Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
May 2015 (Actual)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
August 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatic Diseases
Keywords
Climatotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Climate therapy
Arm Type
Experimental
Arm Description
Climate therapy consisting of 3 week stay at rehabilitation facility in Spain
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Usual care provided as needed / agreed between patient and health care providers
Intervention Type
Other
Intervention Name(s)
Rehabilitation in warm climate
Primary Outcome Measure Information:
Title
Coping (Effective Consumer Scale (EC17)
Description
Measured with Effective Consumer Scale (EC17)
Time Frame
12 months
Title
30 second sit to stand test
Time Frame
12 months
Secondary Outcome Measure Information:
Title
EQ5D
Time Frame
12 months
Title
Numerical Rating Scales (NRS) fatigue question
Time Frame
12 months
Title
Hannover functional Scale
Time Frame
12 months
Title
Coop Wonca
Time Frame
12 months
Title
Hopkins Symptom Checklist
Time Frame
12 months
Title
Patient Specific Functional scale
Time Frame
12 months
Title
Numerical Rating Scales (NRS) pain question
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Inflammatory rheumatic disease
Self reliant in daily life
Exclusion Criteria:
- 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aslak Steinsbekk, PhD
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute for Social Medicine
City
Trondheim
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
32179929
Citation
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.
Results Reference
result
Learn more about this trial
Rehabilitation of Young Patients With Rheumatic Diseases in a Warm Climate
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