The Effect of Intradialytic Exercise on the Physical Function of People Undergoing Hemodialysis

Frail Elderly Syndrome Clinical Trial

— IDEX  

Official title:

The Effect of Intradialytic Resistance Exercises Using Resistance Bands With Exercise Physiologist Consultation on the Physical Function of People Undergoing Hemodialysis: a Proof of Concept Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03944824
• Other study ID #: SH066IDEX
• Status: Completed
• Phase: N/A
• Start date: February 22, 2019
• Est. completion date: July 17, 2019

Study information

• Verified date: September 2019
• Source: Satellite Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators intend to recruit 50 patients into an intradialytic exercise study that will measure the impact of resistance bands exercises under the guidance of an exercise physiologist on the physical function of hemodialysis patients.

Description:

The primary objective of this study will be to test the feasibility and efficacy of a 3 month exercise physiologist consultation program. Specifically, the investigator's aims will be to:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: July 17, 2019
• Est. primary completion date: July 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 years or greater

• 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:

• Previous major amputations

• Inability to independently ambulate

• Known to be pregnant

Related Conditions & MeSH terms

• End Stage Renal Failure on Dialysis
• Frail Elderly Syndrome
• Kidney Failure, Chronic

Intervention

Other:
• 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

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
United States	Satellite Milpitas	Milpitas	California

Sponsors (1)

Lead Sponsor	Collaborator
Satellite Healthcare

Country where clinical trial is conducted

United States, 

References & Publications (14)

Anding K, Bär 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Guio BM, Gomes CP, Costa FBD, Oliveira ADS, Duarte MT, Leite M Júnior. Beneficial effects of intradialytic cardiopulmonary rehabilitation. J Bras Nefrol. 2017 Jul-Sep;39(3):275-282. doi: 10.5935/0101-2800.20170051. English, Portuguese. — View Citation

Heiwe S, Jacobson SH. Exercise training for adults with chronic kidney disease. Cochrane Database Syst Rev. 2011 Oct 5;(10):CD003236. doi: 10.1002/14651858.CD003236.pub2. Review. — View Citation

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. — View Citation

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. Erratum in: J Ren Nutr. 2015 Jul;25(4):397. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Patient Adherence to Exercise Regimen	Adherence calculated as the total number of self-reported exercise sessions attempted by the patient when EP not present divided by the total number of hemodialysis sessions.	12 weeks
Primary	Rate of Adverse Events Secondary to Exercises	Adverse events defined as any injury, impairment or medical condition that was directly or suspected to be due to performing the prescribed exercise. This information will be collected from the patient at the weekly meeting with the EPs.	12 weeks
Secondary	Change in Sit-To-Stand Test	Change in physical function as measured by the 30 second sit to stand test (STS)	12 weeks
Secondary	Change in Handgrip Strength Test	Change in handgrip strength following the 12 week intervention as measured by a handgrip dynanometer	12 weeks
Secondary	Change in Timed Up and Go Test	Change in 8 foot timed up and go test (TUG).	12 weeks