Rehabilitation of Young Patients With Rheumatic Diseases in a Warm Climate

March 18, 2020 updated by: Norwegian University of Science and Technology

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Trondheim, Norway
        • Institute for Social Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 35 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Coping (Effective Consumer Scale (EC17)
Time Frame: 12 months
Measured with Effective Consumer Scale (EC17)
12 months
30 second sit to stand test
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
EQ5D
Time Frame: 12 months
12 months
Numerical Rating Scales (NRS) fatigue question
Time Frame: 12 months
12 months
Hannover functional Scale
Time Frame: 12 months
12 months
Coop Wonca
Time Frame: 12 months
12 months
Hopkins Symptom Checklist
Time Frame: 12 months
12 months
Patient Specific Functional scale
Time Frame: 12 months
12 months
Numerical Rating Scales (NRS) pain question
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian University of Science and Technology

Collaborators

St. Olavs Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2015

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

April 22, 2015

First Submitted That Met QC Criteria

April 29, 2015

First Posted (Estimate)

April 30, 2015

Study Record Updates

Last Update Posted (Actual)

March 20, 2020

Last Update Submitted That Met QC Criteria

March 18, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 013.5

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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