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

NCT ID: NCT02397798

Last Updated: 2021-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2020-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention

Person-centered high-intense training three times a week under supervision (supervision two times a week) during 5 months

Group Type EXPERIMENTAL

Person-centered high-intense training under supervision

Intervention Type BEHAVIORAL

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

Control

Introduction to health-enhancing physical activity, personalized exercise program to perform at home three times a week during 5 months

Group Type ACTIVE_COMPARATOR

Personalized exercise program to perform at home

Intervention Type BEHAVIORAL

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

Interventions

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Person-centered high-intense training under supervision

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

Intervention Type 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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vastra Gotaland Region

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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VastraGotaland

Gothenburg, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type DERIVED
PMID: 32467712 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29696812 (View on PubMed)

Other Identifiers

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PEp-walk study

Identifier Type: -

Identifier Source: org_study_id

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