Rheumatoid ArthritisNCT02397798
Improved Ability to Cope With Everyday Life Through a Person-centered Training Program in Elderly Patients With Rheumatoid Arthritis - PEP-walk Study
A study testing Person-centered high-intense training under supervision and Personalized exercise program to perform at home in people with Rheumatoid Arthritis, run by Vastra Gotaland Region at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Person-centered high-intense training under supervision and Personalized exercise program to perform at home
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteSweden
- Study dates
- Feb 2015to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Person-centered high-intense training under supervision, Personalized exercise program to perform at home
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Person-centered high-intense training under supervisionBehavioural
A person-centered training program including a person-centered high-intense aerobic / strength training
Personalized exercise program to perform at homeBehavioural
Introduction to health-enhancing physical activity, personalized exercise program to perform at home three times a week
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Person-centered high-intense training three times a week under supervision (supervision two times a week) during 5 months Receives: 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 Receives: Behavioral: Personalized exercise program to perform at home |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability to manage daily activities as measured by the rheumatoid arthritis-specific measure of the Health Assessment Questionnaire (HAQ).
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completionDec 2017
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02397798
- Sponsor's protocol ID
- PEp-walk study
- Status last verified
- Jun 2020
- First submitted
- 19 Mar 2015
- Last updated
- 19 Apr 2021
- Results posted
- No
Publications
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.
PubMed 32467712Lange 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.
PubMed 29696812
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improved Ability to Cope With Everyday Life Through a Person-centered Training Program in Elderly Patients With Rheumatoid Arthritis - PEP-walk Study
- ClinicalTrials.gov ID
- NCT02397798
- Acronym / sponsor ID
- PEp-walk study
- Conditions
- Rheumatoid Arthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- Feb 2015 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 25 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Person-centered high-intense training under supervisionPerson-centered high-intense training three times a week under supervision (supervision two times a week) during 5 months |
| Control | Active comparator | Behavioral: Personalized exercise program to perform at homeIntroduction to health-enhancing physical activity, personalized exercise program to perform at home three times a week during 5 months |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Person-centered high-intense training under supervisionA person-centered training program including a person-centered high-intense aerobic / strength training | Behavioural | Intervention |
| Personalized exercise program to perform at homeIntroduction to health-enhancing physical activity, personalized exercise program to perform at home three times a week | Behavioural | Control |
Primary outcome
Ability to manage daily activities as measured by the rheumatoid arthritis-specific measure of the Health Assessment Questionnaire (HAQ).
Time frame: 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2021.
- Derived from this study: PubMed 32467712Andersson 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.
- Derived from this study: PubMed 29696812Lange 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Person-centered high-intense training under supervision and Personalized exercise program to perform at home in people with Rheumatoid Arthritis, run by Vastra Gotaland Region at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ability to manage daily activities as measured by the rheumatoid arthritis-specific measure of the Health Assessment Questionnaire (HAQ). (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02397798, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2021.