The Effect of Intradialytic Exercise on the Physical Function of People Undergoing Hemodialysis
NCT ID: NCT03944824
Last Updated: 2019-09-23
Study Results
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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COMPLETED
NA
46 participants
INTERVENTIONAL
2019-02-22
2019-07-17
Brief Summary
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Detailed Description
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1. Test the feasibility of a 3-month exercise physiologist led program
2. Measure the effect of an exercise physiologist collaboration and intradialytic exercise on the physical function of HD patients using the 30 second STS test, handgrip strength test \[required for frailty scale\], 8-foot TUG test and patient physical activity based off of the Low Physical Activity Questionnaire.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Exercise (Intervention) Arm
The 25 patients in this arm will receive an interventional exercise plan using resistance bands and once weekly visits from an exercise physiologist while on dialysis for 12 weeks. They will undergo a frailty screening using a Modified Fried Frailty Scale at the beginning and end of the trial to include: Timed up and Go test, Sit-to-Stand Test, Handgrip Strength Test, Low physical activity questionnaire.
Exercise Plan using resistance bands
Exercise under the guidance of an exercise physiologist using elastic resistance bands and weekly meeting with an exercise physiologist for 12 weeks
Modified Fried Frailty Scale
Patients will be screened for frailty pre and post with sit-to-stand test, timed up and go test, handgrip strength test and administered the low physical activity questionnaire. These components together consist of the Modified Fried Frailty Index.
Control
The 25 patients in the control arm will not receive an interventional exercise plan or visits from an exercise physiologist while on dialysis for 12 weeks. They will undergo a frailty screening using a Modified Fried Frailty Scale at the beginning and end of the trial to include: Timed up and Go test, Sit-to-Stand Test, Handgrip Strength Test, Low physical activity questionnaire.
Modified Fried Frailty Scale
Patients will be screened for frailty pre and post with sit-to-stand test, timed up and go test, handgrip strength test and administered the low physical activity questionnaire. These components together consist of the Modified Fried Frailty Index.
Interventions
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Exercise Plan using resistance bands
Exercise under the guidance of an exercise physiologist using elastic resistance bands and weekly meeting with an exercise physiologist for 12 weeks
Modified Fried Frailty Scale
Patients will be screened for frailty pre and post with sit-to-stand test, timed up and go test, handgrip strength test and administered the low physical activity questionnaire. These components together consist of the Modified Fried Frailty Index.
Eligibility Criteria
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Inclusion Criteria
* Ability to understand and communicate English
* Diagnosis of ESRD and currently undergoing in-center hemodialysis
* On HD for longer than 6 weeks
* Approved by the Satellite Milpitas Medical Director and/or referring physician
Exclusion Criteria
* Inability to independently ambulate
* Known to be pregnant
18 Years
ALL
No
Sponsors
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Satellite Healthcare
OTHER
Responsible Party
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Locations
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Satellite Milpitas
Milpitas, California, United States
Countries
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References
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Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.
Bao Y, Dalrymple L, Chertow GM, Kaysen GA, Johansen KL. Frailty, dialysis initiation, and mortality in end-stage renal disease. Arch Intern Med. 2012 Jul 23;172(14):1071-7. doi: 10.1001/archinternmed.2012.3020.
McAdams-DeMarco MA, Law A, Salter ML, Boyarsky B, Gimenez L, Jaar BG, Walston JD, Segev DL. Frailty as a novel predictor of mortality and hospitalization in individuals of all ages undergoing hemodialysis. J Am Geriatr Soc. 2013 Jun;61(6):896-901. doi: 10.1111/jgs.12266. Epub 2013 May 27.
Johansen KL, Delgado C, Kaysen GA, Chertow GM, Chiang J, Dalrymple LS, Segal MR, Grimes BA. Frailty Among Patients Receiving Hemodialysis: Evolution of Components and Associations With Mortality. J Gerontol A Biol Sci Med Sci. 2019 Feb 15;74(3):380-386. doi: 10.1093/gerona/gly206.
Heiwe S, Jacobson SH. Exercise training for adults with chronic kidney disease. Cochrane Database Syst Rev. 2011 Oct 5;2011(10):CD003236. doi: 10.1002/14651858.CD003236.pub2.
Cho JH, Lee JY, Lee S, Park H, Choi SW, Kim JC. Effect of intradialytic exercise on daily physical activity and sleep quality in maintenance hemodialysis patients. Int Urol Nephrol. 2018 Apr;50(4):745-754. doi: 10.1007/s11255-018-1796-y. Epub 2018 Jan 23.
Guio BM, Gomes CP, Costa FBD, Oliveira ADS, Duarte MT, Leite M Junior. Beneficial effects of intradialytic cardiopulmonary rehabilitation. J Bras Nefrol. 2017 Jul-Sep;39(3):275-282. doi: 10.5935/0101-2800.20170051. English, Portuguese.
Young HML, March DS, Graham-Brown MPM, Jones AW, Curtis F, Grantham CS, Churchward DR, Highton P, Smith AC, Singh SJ, Bridle C, Burton JO. Effects of intradialytic cycling exercise on exercise capacity, quality of life, physical function and cardiovascular measures in adult haemodialysis patients: a systematic review and meta-analysis. Nephrol Dial Transplant. 2018 Aug 1;33(8):1436-1445. doi: 10.1093/ndt/gfy045.
Gomes Neto M, de Lacerda FFR, Lopes AA, Martinez BP, Saquetto MB. Intradialytic exercise training modalities on physical functioning and health-related quality of life in patients undergoing maintenance hemodialysis: systematic review and meta-analysis. Clin Rehabil. 2018 Sep;32(9):1189-1202. doi: 10.1177/0269215518760380. Epub 2018 Feb 26.
Bennett PN, Fraser S, Barnard R, Haines T, Ockerby C, Street M, Wang WC, Daly R. Effects of an intradialytic resistance training programme on physical function: a prospective stepped-wedge randomized controlled trial. Nephrol Dial Transplant. 2016 Aug;31(8):1302-9. doi: 10.1093/ndt/gfv416. Epub 2015 Dec 28.
Anding K, Bar T, Trojniak-Hennig J, Kuchinke S, Krause R, Rost JM, Halle M. A structured exercise programme during haemodialysis for patients with chronic kidney disease: clinical benefit and long-term adherence. BMJ Open. 2015 Aug 27;5(8):e008709. doi: 10.1136/bmjopen-2015-008709.
Bennett PN, Peter J, Wang W, Street M. Attitudes of Nephrology Nurses Toward Patient Exercise During Hemodialysis. Nephrol Nurs J. 2016 Jul-Aug;43(4):331-337.
Bennett PN, Daly RM, Fraser SF, Haines T, Barnard R, Ockerby C, Kent B. The impact of an exercise physiologist coordinated resistance exercise program on the physical function of people receiving hemodialysis: a stepped wedge randomised control study. BMC Nephrol. 2013 Sep 27;14:204. doi: 10.1186/1471-2369-14-204.
Johansen KL, Painter P, Delgado C, Doyle J. Characterization of physical activity and sitting time among patients on hemodialysis using a new physical activity instrument. J Ren Nutr. 2015 Jan;25(1):25-30. doi: 10.1053/j.jrn.2014.06.012. Epub 2014 Sep 8.
Provided Documents
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Document Type: Informed Consent Form
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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SH066IDEX
Identifier Type: -
Identifier Source: org_study_id
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