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

• Sponsor: Vastra Gotaland Region (Other)
• Overall Status: Completed
• CT.gov ID: NCT02397798
• Collaborator: (none)
• Enrollment: 75
• Location: 1
• Arms: 2
• Actual Duration (Months): 70
• Patients Per Site Per Month: 1.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis	Behavioral: Person-centered high-intense training under supervision; Behavioral: Personalized exercise program to perform at home	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 75 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
• Actual Study Start Date: Feb 1, 2015
• Actual Primary Completion Date: Dec 1, 2017
• Actual Study Completion Date: Dec 1, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VastraGotaland	Gothenburg		Sweden

Sponsors and Collaborators

• Vastra Gotaland Region

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Vastra Gotaland Region
• ClinicalTrials.gov Identifier: NCT02397798
• Other Study ID Numbers: PEp-walk study
• First Posted: Mar 25, 2015
• Last Update Posted: Apr 19, 2021
• Last Verified: Jun 1, 2020

• Additional relevant MeSH terms: Arthritis; Arthritis, Rheumatoid

Study Results

No Results Posted as of Apr 19, 2021