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Improved Ability to Cope With Everyday Life Through a Person-centered Training Program in Elderly Patients With Rheumatoid Arthritis - PEP-walk Study

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ClinicalTrials.gov Identifier: NCT02397798
Recruitment Status : Unknown
Verified October 2015 by Vastra Gotaland Region.
Recruitment status was:  Recruiting
First Posted : March 25, 2015
Last Update Posted : October 20, 2015
Sponsor:
Information provided by (Responsible Party):
Vastra Gotaland Region

Brief Summary:
The purpose of this study is to examine whether person-centered high-intense aerobic / strength training during five months reduces inflammation and disease activity, improve immune cell function, and increases muscle strength, fitness and ability of the individual independence in elderly patients with rheumatoid arthritis.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Behavioral: Person-centered high-intense training under supervision Behavioral: Personalized exercise program to perform at home Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Improved Ability to Cope With Everyday Life Through a Person-centered Training Program in Elderly Patients With Rheumatoid Arthritis - PEP-walk Study
Study Start Date : February 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
Person-centered high-intense training three times a week under supervision (supervision two times a week) during 5 months
Behavioral: Person-centered high-intense training under supervision
A person-centered training program including a person-centered high-intense aerobic / strength training

Active Comparator: Control
Introduction to health-enhancing physical activity, personalized exercise program to perform at home three times a week during 5 months
Behavioral: Personalized exercise program to perform at home
Introduction to health-enhancing physical activity, personalized exercise program to perform at home three times a week




Primary Outcome Measures :
  1. Ability to manage daily activities as measured by the rheumatoid arthritis-specific measure of the Health Assessment Questionnaire (HAQ). [ Time Frame: 5 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion

  • Patients 65 years or older with RA diagnosed according to the ACR / EULAR 1987/2010 criteria,
  • disease duration 2 years or more,
  • disease activity as measured by DAS28 <5.1

Exclusion

  • Comorbidities, such as unstable coronary artery disease, uncontrolled cardiac arrhythmia, or uncontrolled high blood pressure, which prevents moderate to intense exercise.
  • Joint surgery completed within 6 months prior to study entry.
  • Ongoing training at moderate to high level 2 or more times per week

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): NCT02397798


Locations
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Sweden
VastraGotaland Recruiting
Gothenburg, Sweden
Contact: Inger Gjertsson, MD       inger.gjertsson@rheuma.gu.se   
Principal Investigator: Inger Gjertsson         
Sponsors and Collaborators
Vastra Gotaland Region
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Vastra Gotaland Region
ClinicalTrials.gov Identifier: NCT02397798    
Other Study ID Numbers: PEp-walk study
First Posted: March 25, 2015    Key Record Dates
Last Update Posted: October 20, 2015
Last Verified: October 2015
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases