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

NCT02397798 | Completed

• 1 other identifier: PEp-walk study
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Ability to manage daily activities as measured by the rheumatoid arthritis-specific measure of the Health Assessment Questionnaire (HAQ).

  5 months

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

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

Interventions

Person-centered high-intense training under supervision BEHAVIORAL

A person-centered training program including a person-centered high-intense aerobic / strength training

Intervention

Personalized exercise program to perform at home BEHAVIORAL

Introduction to health-enhancing physical activity, personalized exercise program to perform at home three times a week

Control

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vastra Gotaland Region: lead

Study Sites (1)

VastraGotaland

Gothenburg, Sweden

Location

Related Publications (2)

• 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.

  PMID: 32467712 DERIVED

• 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.

  PMID: 29696812 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2015
• First Posted: March 25, 2015
• Study Start: February 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2020
• Last Updated: April 19, 2021

Record last verified: 2020-06

Locations

SE (1)