Back to resultsImproved Ability to Cope With Everyday Life Through a Person-centered Training Program in Elderly Patients With Rheumatoid Arthritis - PEP-walk Study
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Person-centered high-intense training under supervision
Personalized exercise program to perform at home
Sponsored by
About this trial
This is an interventional supportive care trial for Rheumatoid Arthritis
Eligibility 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
Sites / Locations
- VastraGotaland
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention
Control
Arm Description
Person-centered high-intense training three times a week under supervision (supervision two times a week) during 5 months
Introduction to health-enhancing physical activity, personalized exercise program to perform at home three times a week during 5 months
Outcomes
Primary Outcome Measures
Ability to manage daily activities as measured by the rheumatoid arthritis-specific measure of the Health Assessment Questionnaire (HAQ).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02397798
Brief Title
Improved Ability to Cope With Everyday Life Through a Person-centered Training Program in Elderly Patients With Rheumatoid Arthritis - PEP-walk Study
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 Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
February 2015 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vastra Gotaland Region
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Person-centered high-intense training three times a week under supervision (supervision two times a week) during 5 months
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Introduction to health-enhancing physical activity, personalized exercise program to perform at home three times a week during 5 months
Intervention Type
Behavioral
Intervention Name(s)
Person-centered high-intense training under supervision
Intervention Description
A person-centered training program including a person-centered high-intense aerobic / strength training
Intervention Type
Behavioral
Intervention Name(s)
Personalized exercise program to perform at home
Intervention Description
Introduction to health-enhancing physical activity, personalized exercise program to perform at home three times a week
Primary Outcome Measure Information:
Title
Ability to manage daily activities as measured by the rheumatoid arthritis-specific measure of the Health Assessment Questionnaire (HAQ).
Time Frame
5 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
VastraGotaland
City
Gothenburg
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
32467712
Citation
Andersson SEM, Lange E, Kucharski D, Svedlund S, Onnheim K, Bergquist M, Josefsson E, Lord JM, Martensson IL, Mannerkorpi K, Gjertsson I. Moderate- to high intensity aerobic and resistance exercise reduces peripheral blood regulatory cell populations in older adults with rheumatoid arthritis. Immun Ageing. 2020 May 16;17:12. doi: 10.1186/s12979-020-00184-y. eCollection 2020.
Results Reference
derived
PubMed Identifier
29696812
Citation
Lange E, Kucharski D, Svedlund S, Svensson K, Bertholds G, Gjertsson I, Mannerkorpi K. Effects of Aerobic and Resistance Exercise in Older Adults With Rheumatoid Arthritis: A Randomized Controlled Trial. Arthritis Care Res (Hoboken). 2019 Jan;71(1):61-70. doi: 10.1002/acr.23589.
Results Reference
derived
Learn more about this trial
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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