Ignite Creation Date:
2025-12-24 @ 1:55 PM
Ignite Modification Date:
2026-02-06 @ 6:43 PM
Study NCT ID:
NCT03140995
Status:
COMPLETED
Last Update Posted:
2019-07-08
First Post:
2017-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sleep and Exercise in Rheumatoid Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'At baseline assessment demographic information and outcome measures will be collected by a physiotherapist not involved in the intervention and will be blinded to which arm the participant has been allocated to. This will all take place at the Department of Clinical Therapies, University of Limerick.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Single centre, single blinded pilot randomised controlled trial, comparing an aerobic intermittent exercise training intervention (walking programme) against verbal and written instructions regarding the benefits of exercise in RA.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2018-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-04', 'studyFirstSubmitDate': '2017-04-25', 'studyFirstSubmitQcDate': '2017-05-03', 'lastUpdatePostDateStruct': {'date': '2019-07-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pittsburgh Sleep Quality Index', 'timeFrame': '8 Weeks', 'description': 'Sleep'}], 'secondaryOutcomes': [{'measure': 'RA related Pain - visual analog scale (VAS) consisting of a 10cm horizontal line anchored from 0 (no pain) to 10 (worst pain possible).', 'timeFrame': 'up to 8 weeks follow up', 'description': 'Pain'}, {'measure': 'Profile of Moods State', 'timeFrame': 'up to 8 weeks', 'description': 'Mood'}, {'measure': 'Quick Inventory of Depressive Symptomatology', 'timeFrame': 'up to 8 weeks', 'description': 'Depression'}, {'measure': 'State Trait Anxiety Inventory', 'timeFrame': 'up to 8 weeks', 'description': 'Anxiety'}, {'measure': 'Health Assessment disability Index', 'timeFrame': 'up to 8 weeks', 'description': 'Functional limitation'}, {'measure': 'Disease Activity Score with 28 joints', 'timeFrame': 'up to 8 weeks', 'description': 'Disease activity'}, {'measure': 'Rheumatoid Arthritis-Specific Quality of Life Instrument', 'timeFrame': 'up to 8 weeks', 'description': 'Quality of Life'}, {'measure': 'Bristol Rheumatoid Arthritis Fatigue Multi-Dimensional Questionnaire', 'timeFrame': 'up to 8 weeks', 'description': 'Fatigue'}, {'measure': 'Exercise Benefits and Barriers Scale', 'timeFrame': 'up to 8 weeks', 'description': 'Exercise barriers'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Exercise', 'Sleep'], 'conditions': ['Rheumatoid Arthritis', 'Inflammatory Arthritis']}, 'referencesModule': {'references': [{'pmid': '28251248', 'type': 'RESULT', 'citation': 'McKenna S, Donnelly A, Fraser A, Comber L, Kennedy N. Does exercise impact on sleep for people who have rheumatoid arthritis? A systematic review. Rheumatol Int. 2017 Jun;37(6):963-974. doi: 10.1007/s00296-017-3681-x. Epub 2017 Mar 1.'}, {'pmid': '28573870', 'type': 'RESULT', 'citation': 'McKenna S, Donnelly A, Fraser A, Kennedy N. Sleep and physical activity: a survey of people with inflammatory arthritis and their engagement by health professionals in rheumatology in Ireland. Disabil Rehabil. 2018 Sep;40(19):2260-2266. doi: 10.1080/09638288.2017.1334095. Epub 2017 Jun 2.'}, {'pmid': '29541902', 'type': 'RESULT', 'citation': "McKenna S, Tierney M, O'Neill A, Fraser A, Kennedy N. Sleep and physical activity: a cross-sectional objective profile of people with rheumatoid arthritis. Rheumatol Int. 2018 May;38(5):845-853. doi: 10.1007/s00296-018-4009-1. Epub 2018 Mar 14."}, {'pmid': '29644891', 'type': 'RESULT', 'citation': "McKenna S, Kelly G, Kennedy N. A survey of physiotherapists' current management and the promotion of physical activity, in people with rheumatoid arthritis. Disabil Rehabil. 2019 Sep;41(18):2183-2191. doi: 10.1080/09638288.2018.1461258. Epub 2018 Apr 12."}, {'pmid': '29766257', 'type': 'RESULT', 'citation': 'McKenna SG, Donnelly AE, Esbensen BA, Fraser AD, Kennedy NM. The impact of exercise on sleep (time, quality, and disturbance) in patients with rheumatoid arthritis: a study protocol for a pilot randomised controlled trial. Rheumatol Int. 2018 Jul;38(7):1191-1198. doi: 10.1007/s00296-018-4052-y. Epub 2018 May 15.'}, {'pmid': '33386901', 'type': 'DERIVED', 'citation': 'McKenna SG, Donnelly A, Esbensen BA, Comber L, Ng WL, Anjum AM, Fraser A, Kennedy NM. The feasibility of an exercise intervention to improve sleep (time, quality and disturbance) in people with rheumatoid arthritis: a pilot RCT. Rheumatol Int. 2021 Feb;41(2):297-310. doi: 10.1007/s00296-020-04760-9. Epub 2021 Jan 2.'}], 'seeAlsoLinks': [{'url': 'https://link.springer.com/article/10.1007/s00296-018-4052-y', 'label': 'The impact of exercise on sleep (time, quality, and disturbance) in patients with rheumatoid arthritis: a study protocol for a pilot randomised controlled trial'}]}, 'descriptionModule': {'briefSummary': "Regular physical activity is important for people with rheumatoid arthritis (RA). Sleep requirements for adults should be on a 'sleep needs spectrum' of between 7 to 9 hours per day. Poor sleep is a common complaint among people with RA, which may have an effect on their activity levels and well-being. There is evidence that physical activity and exercise can improve sleep quality and disturbances in other chronic disease populations therefore, examining how same affects sleep in RA is important.", 'detailedDescription': "Sleep is an important aspect in maintaining the body's circadian rhythm. In general getting fewer than 5 hours sleep per day has been associated with cardiovascular problems, diabetes and obesity and can also be linked to depression and anxiety. Poor sleep is a common complaint among people with rheumatoid arthritis (RA) with disturbed sleep and fatigue known to affect up to 70% in this population. Poor sleep quality may contribute to the feelings of pain, fatigue and poor psychological well-being which in turn may further deteriorate functional ability and reduced activity.\n\nIt is known that exercise improves a person's psychological state which can also be an additional factor in improving or indeed disrupting quality of sleep. Exercise has been identified as an important part of the nonpharmacological management of poor sleep and in improving sleep quality however, people with RA were previously cautioned about undertaking exercise. Therefore, changes in sleep quality during exercise intervention should be evaluated so that society can understand more the potential for long-term changes in overall health status, in people who have RA. Indeed the intensity level of the activity in people with RA may be of additional importance."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants will be eligible to participate if they are aged 18-70; have a diagnosis of RA (defined by the American College of Rheumatology 1987 criteria); have poor sleep (Pittsburgh Sleep Quality Index global score \\>5); have a low disease score on 28 joints (DAS28) \\<3.2; Health Assessment Questionnaire result of \\<2.4 and are able to provided informed consent, understand and speak English. All the above will be determined should the person be interested in participating and before any fitness testing will be place.\n\nExclusion Criteria:\n\n* Participants will be excluded from the study if they have severe physical disability (HAQ score \\> 2.5); are pregnant; participate in regular physical activity in their leisure time (self-reported aerobic exercise \\> 5 times per week); have cardiac symptoms corresponding to New York Heart Association (NYHA) functional classification \\> 2;'}, 'identificationModule': {'nctId': 'NCT03140995', 'briefTitle': 'Sleep and Exercise in Rheumatoid Arthritis', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital of Limerick'}, 'officialTitle': 'Does Exercise Have an Impact on Sleep and Mood in People Who Have Rheumatoid Arthritis: a Pilot Randomised Controlled Trial', 'orgStudyIdInfo': {'id': 'GOIPG/2016/58'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Exercise Intervention', 'description': 'The walking programme will consist of a total of 21 aerobic walking sessions, with 1 per week being supervised by a trained physiotherapist, spread over a maximum of eight weeks (2-3 times/week). During the first 4 weeks the intention is to increase frequency and the final 4 weeks the intensity, using the Borg Rate of Perceived exertion 6-20 or distance from 2km to 6km. The participants will attend the University of Limerick for a final assessment at week 9.', 'interventionNames': ['Behavioral: Walking Programme']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'The control group will be given verbal and written instructions regarding the benefits of exercise in RA.'}], 'interventions': [{'name': 'Walking Programme', 'type': 'BEHAVIORAL', 'description': 'The programme will be devised using incremental targets for daily walks based on the 6-20 Borg of rating of perceived exertion scale (Borg RPE). They will be instructed that they should be moderately short of breath on exertion i.e. unable to comfortably hold a conversation while walking', 'armGroupLabels': ['Exercise Intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Limerick', 'state': 'Cork', 'country': 'Ireland', 'facility': 'University Hospitals Limerick', 'geoPoint': {'lat': 52.66472, 'lon': -8.62306}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF', 'CSR'], 'timeFrame': 'Early 2020', 'ipdSharing': 'YES', 'description': "The investigating team only will have access to the patient's names and/or identifying factors for participants at the site and University of Limerick (UL) researchers will have access to the full data set from the single site. Participants will be allocated a study code. Thereafter It is anticipated that the results will be used in presentations to conferences such as European League against Rheumatism (EULAR) and American College of Rheumatology (ACR). Additionally papers will be prepared for submission to peer reviewed journals, through Arthritis Ireland and the UL Research office. Results will also be made available at aggregate level to Consultant Rheumatologists Dr. Alexander Fraser and Dr. Joe Devlin, Department of Rheumatology, University Hospitals Limerick. Results will be shared via supplementary material thereafter."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital of Limerick', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Limerick', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD Candidate', 'investigatorFullName': 'Sean McKenna', 'investigatorAffiliation': 'University Hospital of Limerick'}}}}