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Rehabilitation of Young Patients With Rheumatic Diseases in a Warm Climate

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ClinicalTrials.gov Identifier: NCT02430402
Recruitment Status : Completed
First Posted : April 30, 2015
Last Update Posted : August 17, 2017
Sponsor:
Collaborator:
St. Olavs Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology

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.

Condition or disease Intervention/treatment Phase
Rheumatic Diseases Other: Rehabilitation in warm climate Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Rehabilitation of Young Patients With Rheumatic Diseases in a Warm Climate. A Pilot Randomised Controlled Trial
Actual Study Start Date : May 2015
Actual Primary Completion Date : August 2017
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: Climate therapy
Climate therapy consisting of 3 week stay at rehabilitation facility in Spain
Other: Rehabilitation in warm climate
No Intervention: Usual care
Usual care provided as needed / agreed between patient and health care providers



Primary Outcome Measures :
  1. Coping (Effective Consumer Scale (EC17) [ Time Frame: 12 months ]
    Measured with Effective Consumer Scale (EC17)

  2. 30 second sit to stand test [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. EQ5D [ Time Frame: 12 months ]
  2. Numerical Rating Scales (NRS) fatigue question [ Time Frame: 12 months ]
  3. Hannover functional Scale [ Time Frame: 12 months ]
  4. Coop Wonca [ Time Frame: 12 months ]
  5. Hopkins Symptom Checklist [ Time Frame: 12 months ]
  6. Patient Specific Functional scale [ Time Frame: 12 months ]
  7. Numerical Rating Scales (NRS) pain question [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02430402


Locations
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Norway
Institute for Social Medicine
Trondheim, Norway
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
Investigators
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Principal Investigator: Aslak Steinsbekk, PhD Norwegian University of Science and Technology

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Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT02430402     History of Changes
Other Study ID Numbers: 013.5
First Posted: April 30, 2015    Key Record Dates
Last Update Posted: August 17, 2017
Last Verified: August 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Norwegian University of Science and Technology:
Climatotherapy
Additional relevant MeSH terms:
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Rheumatic Diseases
Collagen Diseases
Musculoskeletal Diseases
Connective Tissue Diseases