NCT02430402

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 22, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 30, 2015

Completed
1 day until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

March 20, 2020

Status Verified

March 1, 2020

Enrollment Period

2.3 years

First QC Date

April 22, 2015

Last Update Submit

March 18, 2020

Conditions

Keywords

Climatotherapy

Outcome Measures

Primary Outcomes (2)

  • Coping (Effective Consumer Scale (EC17)

    Measured with Effective Consumer Scale (EC17)

    12 months

  • 30 second sit to stand test

    12 months

Secondary Outcomes (7)

  • EQ5D

    12 months

  • Numerical Rating Scales (NRS) fatigue question

    12 months

  • Hannover functional Scale

    12 months

  • Coop Wonca

    12 months

  • Hopkins Symptom Checklist

    12 months

  • +2 more secondary outcomes

Study Arms (2)

Climate therapy

EXPERIMENTAL

Climate therapy consisting of 3 week stay at rehabilitation facility in Spain

Other: Rehabilitation in warm climate

Usual care

NO INTERVENTION

Usual care provided as needed / agreed between patient and health care providers

Interventions

Climate therapy

Eligibility Criteria

Age20 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Inflammatory rheumatic disease
  • Self reliant in daily life

You may not qualify if:

  • \- 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute for Social Medicine

Trondheim, Norway

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Rheumatic Diseases

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Musculoskeletal DiseasesConnective Tissue DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

AftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Aslak Steinsbekk, PhD

    Norwegian University of Science and Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2015

First Posted

April 30, 2015

Study Start

May 1, 2015

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

March 20, 2020

Record last verified: 2020-03

Locations