Effectiveness of promotion and support for physical activity maintenance post total hip arthroplasty-study protocol for a pragmatic, assessor-blinded, randomized controlled trial (the PANORAMA trial).
Behavior change intervention
Motivation
Pedometer
Physical activity
Physical function
Randomized controlled trial
Total hip arthroplasty
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
13 Aug 2022
13 Aug 2022
Historique:
received:
24
05
2022
accepted:
01
08
2022
entrez:
13
8
2022
pubmed:
14
8
2022
medline:
17
8
2022
Statut:
epublish
Résumé
Total hip arthroplasty is considered an efficacious procedure for relieving pain and disability, but despite that objectively measured physical activity level remains unchanged compared to pre-surgery and is still considerably lower than that of a healthy age- and sex-matched population 6-12 months post-surgery. Since there is a graded relationship between physical activity level and functional performance, increasing physical activity may enhance the outcome of the procedure. This study aims to investigate whether promotion and support of physical activity initiated 3 months after total hip arthroplasty complementary to usual rehabilitation care can increase objective measured physical activity 6 months post-surgery. The trial is designed as a pragmatic, parallel group, two-arm, assessor-blinded, superiority, randomized (1:1), controlled trial with post intervention follow-up 6 and 12 months after total hip arthroplasty. Home-dwelling, independent, and self-reliant patients with hip osteoarthritis are provisionally enrolled prior to surgery and re-screened about 2-3 months post-surgery to confirm eligibility. Baseline assessment is conducted 3 months post-surgery. Subsequently, patients (n=200) are randomized to either a 3-month, multimodal physical activity promotion/education intervention or control (no further attention). The intervention consists of face-to-face and telephone counselling, patient education material, pedometer, and step-counting journal. The primary outcome is objectively measured physical activity, specifically the proportion of patients that complete on average ≥8000 steps per day 6 months post-surgery. Secondary outcomes include core outcomes (i.e., physical function, pain, and patient global assessment) and health-related quality of life. Furthermore, we will explore the effect of the intervention on self-efficacy and outcome expectations (i.e., tertiary outcomes). By investigating the effectiveness of a pedometer-driven, face-to-face, and telephone-assisted counselling, behavior change intervention in complementary to usual rehabilitation, we hope to deliver applicable and generalizable knowledge to support physical activity after total hip arthroplasty and potentially enhance the outcome of the procedure. www. gov NCT04471532 . Registered on July 15, 2020.
Sections du résumé
BACKGROUND
BACKGROUND
Total hip arthroplasty is considered an efficacious procedure for relieving pain and disability, but despite that objectively measured physical activity level remains unchanged compared to pre-surgery and is still considerably lower than that of a healthy age- and sex-matched population 6-12 months post-surgery. Since there is a graded relationship between physical activity level and functional performance, increasing physical activity may enhance the outcome of the procedure. This study aims to investigate whether promotion and support of physical activity initiated 3 months after total hip arthroplasty complementary to usual rehabilitation care can increase objective measured physical activity 6 months post-surgery.
METHODS
METHODS
The trial is designed as a pragmatic, parallel group, two-arm, assessor-blinded, superiority, randomized (1:1), controlled trial with post intervention follow-up 6 and 12 months after total hip arthroplasty. Home-dwelling, independent, and self-reliant patients with hip osteoarthritis are provisionally enrolled prior to surgery and re-screened about 2-3 months post-surgery to confirm eligibility. Baseline assessment is conducted 3 months post-surgery. Subsequently, patients (n=200) are randomized to either a 3-month, multimodal physical activity promotion/education intervention or control (no further attention). The intervention consists of face-to-face and telephone counselling, patient education material, pedometer, and step-counting journal. The primary outcome is objectively measured physical activity, specifically the proportion of patients that complete on average ≥8000 steps per day 6 months post-surgery. Secondary outcomes include core outcomes (i.e., physical function, pain, and patient global assessment) and health-related quality of life. Furthermore, we will explore the effect of the intervention on self-efficacy and outcome expectations (i.e., tertiary outcomes).
DISCUSSION
CONCLUSIONS
By investigating the effectiveness of a pedometer-driven, face-to-face, and telephone-assisted counselling, behavior change intervention in complementary to usual rehabilitation, we hope to deliver applicable and generalizable knowledge to support physical activity after total hip arthroplasty and potentially enhance the outcome of the procedure.
TRIAL REGISTRATION
BACKGROUND
www.
CLINICALTRIALS
RESULTS
gov NCT04471532 . Registered on July 15, 2020.
Identifiants
pubmed: 35964101
doi: 10.1186/s13063-022-06610-4
pii: 10.1186/s13063-022-06610-4
pmc: PMC9375375
doi:
Banques de données
ClinicalTrials.gov
['NCT04471532']
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
647Subventions
Organisme : TrygFonden
ID : 149688
Organisme : Helsefonden
ID : 20-B-0258
Organisme : Hartmann Fonden
ID : A35081
Informations de copyright
© 2022. The Author(s).
Références
J Arthroplasty. 2018 Nov;33(11):3422-3428
pubmed: 30017217
Osteoarthritis Cartilage. 2013 Nov;21(11):1648-59
pubmed: 23948979
Pharmacoeconomics. 2018 Jun;36(6):645-661
pubmed: 29572719
BMC Musculoskelet Disord. 2005 Jan 28;6:3
pubmed: 15679884
Ann Rheum Dis. 2014 Jul;73(7):1323-30
pubmed: 24553908
Arthritis Care Res (Hoboken). 2018 May;70(5):732-740
pubmed: 28732147
Res Q Exerc Sport. 2009 Dec;80(4):710-7
pubmed: 20025112
J Clin Epidemiol. 2006 Feb;59(2):160-7
pubmed: 16426951
Dan Med J. 2016 Aug;63(8):
pubmed: 27477795
Osteoarthritis Cartilage. 2013 Aug;21(8):1042-52
pubmed: 23680877
J Rheumatol. 1997 Apr;24(4):799-802
pubmed: 9101522
JBJS Rev. 2018 Jan;6(1):e2
pubmed: 29315123
Cochrane Database Syst Rev. 2018 Apr 17;4:CD010842
pubmed: 29664187
J Clin Epidemiol. 2009 May;62(5):464-75
pubmed: 19348971
BMC Musculoskelet Disord. 2014 Jul 10;15:231
pubmed: 25012720
Qual Life Res. 2015 Jul;24(7):1775-84
pubmed: 25555837
Osteoarthritis Cartilage. 2004 May;12(5):389-99
pubmed: 15094138
J Orthop Sci. 2013 Jan;18(1):45-53
pubmed: 23096948
Phys Sportsmed. 2011 Nov;39(4):70-9
pubmed: 22293770
Clin Rehabil. 2015 Feb;29(2):165-74
pubmed: 24849791
Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S350-70
pubmed: 22588756
J Clin Epidemiol. 1993 Feb;46(2):153-62
pubmed: 8437031
PLoS One. 2018 Aug 30;13(8):e0202494
pubmed: 30161163
Postgrad Med J. 2015 Sep;91(1079):483-91
pubmed: 26306502
Arthritis Care Res (Hoboken). 2012 Jan;64(1):54-8
pubmed: 21954220
Nurs Res. 2001 Sep-Oct;50(5):293-9
pubmed: 11570714
Scand J Public Health. 2009 Jul;37(5):467-74
pubmed: 19535407
Scand J Rheumatol. 2003;32(1):46-51
pubmed: 12635946
Res Q Exerc Sport. 1992 Mar;63(1):60-6
pubmed: 1574662
Physiotherapy. 2019 Mar;105(1):35-45
pubmed: 30025714
Res Q Exerc Sport. 1999 Jun;70(2):113-9
pubmed: 10380242
Sports Med. 2009;39(12):981-93
pubmed: 19902981
Ann Behav Med. 2013 Aug;46(1):81-95
pubmed: 23512568
BMJ. 2014 Mar 07;348:g1687
pubmed: 24609605
J Orthop Sports Phys Ther. 2016 Jun;46(6):431-42
pubmed: 27117726
J Gerontol B Psychol Sci Soc Sci. 2001 Sep;56(5):S261-5
pubmed: 11522807
BMC Musculoskelet Disord. 2018 Jun 30;19(1):209
pubmed: 29960605
Clin Rehabil. 2019 Jan;33(1):13-23
pubmed: 30073856
Osteoarthritis Cartilage. 2015 Jun;23(6):860-7
pubmed: 25707933
Women Health. 2005;41(2):97-116
pubmed: 16219590
J Rehabil Med. 2014 Nov;46(10):997-1005
pubmed: 25103138
J Epidemiol Community Health. 2001 Feb;55(2):132-8
pubmed: 11154253
Arthritis Rheum. 2011 Jan;63(1):127-36
pubmed: 20862681
J Arthroplasty. 2017 Sep;32(9):2755-2761
pubmed: 28506675
Eur J Orthop Surg Traumatol. 2014 Dec;24(8):1571-7
pubmed: 24664453
BMJ. 2013 Jan 08;346:e7586
pubmed: 23303884
Int J Behav Nutr Phys Act. 2011 Jul 28;8:79
pubmed: 21798015
Disabil Rehabil. 2014;36(24):2091-100
pubmed: 24564358
BMC Public Health. 2016 Jun 16;16:515
pubmed: 27306667
Arthritis Care Res (Hoboken). 2014 Sep;66(9):1328-36
pubmed: 24923633
Ugeskr Laeger. 2017 Dec 18;179(51):
pubmed: 29260691
BMC Musculoskelet Disord. 2015 Nov 17;16:359
pubmed: 26578262
BMC Musculoskelet Disord. 2003 May 30;4:10
pubmed: 12777182
J Aging Phys Act. 2005 Oct;13(4):382-94
pubmed: 16301750
Scand J Public Health. 2009 Jul;37(5):459-66
pubmed: 19411320
Clin Orthop Relat Res. 2015 Nov;473(11):3383-90
pubmed: 25488404
Phys Ther. 2010 Jul;90(7):1014-25
pubmed: 20466741
Arthritis. 2018 Mar 1;2018:6596278
pubmed: 29686901
Arthritis Rheum. 2007 Oct 15;57(7):1245-53
pubmed: 17907210
Implement Sci. 2011 Apr 23;6:42
pubmed: 21513547
Res Q Exerc Sport. 2007 Dec;78(5):401-6
pubmed: 18274211
Phys Ther. 2011 May;91(5):615-29
pubmed: 21393418
Lancet. 2007 Dec 22;370(9605):2082-4
pubmed: 18156017
Fam Pract. 2006 Oct;23(5):558-67
pubmed: 16731544
Arthritis Care Res (Hoboken). 2020 May;72(5):661-668
pubmed: 30908867
Rheumatol Int. 2015 Jul;35(7):1233-41
pubmed: 25586654
Patient Educ Couns. 2019 Jan;102(1):25-36
pubmed: 30279029
Health Policy. 1990 Dec;16(3):199-208
pubmed: 10109801
J Gerontol A Biol Sci Med Sci. 2014 May;69(5):602-8
pubmed: 24253535
Arthritis Care Res (Hoboken). 2018 Jun;70(6):892-901
pubmed: 28898559
J Aging Phys Act. 2018 Jan 1;26(1):7-13
pubmed: 28338406
Am J Epidemiol. 2003 Oct 1;158(7):639-44
pubmed: 14507599
Arthritis Care Res (Hoboken). 2019 Feb;71(2):237-251
pubmed: 30320970