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

NCT03944824 | Completed

• 1 other identifier: SH066IDEX
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

End Stage Renal Failure on Dialysis; Frail Elderly Syndrome

Keywords

Intra-Dialytic Exercise; End Stage Renal Disease; Hemodialysis; Therabands; Exercise Physiologist

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Change in Sit-To-Stand Test

  12 weeks

• Change in Handgrip Strength Test

  12 weeks

• Change in Timed Up and Go Test

  12 weeks

Study Arms (2)

Exercise (Intervention) Arm

EXPERIMENTAL

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.

Other: Exercise Plan using resistance bands; Diagnostic Test: Modified Fried Frailty Scale

Control

PLACEBO COMPARATOR

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.

Diagnostic Test: Modified Fried Frailty Scale

Interventions

Exercise Plan using resistance bands OTHER

Exercise under the guidance of an exercise physiologist using elastic resistance bands and weekly meeting with an exercise physiologist for 12 weeks

Exercise (Intervention) Arm

Modified Fried Frailty Scale DIAGNOSTIC_TEST

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; Exercise (Intervention) Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Previous major amputations
• Inability to independently ambulate
• Known to be pregnant

Sponsors & Collaborators

• Satellite Healthcare: lead

Study Sites (1)

Satellite Milpitas

Milpitas, California, 95035, United States

Location

Related Publications (14)

• 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.

  PMID: 11253156 BACKGROUND

• 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.

  PMID: 22733312 BACKGROUND

• 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.

  PMID: 23711111 BACKGROUND

• 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.

  PMID: 30192916 BACKGROUND

• 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.

  PMID: 21975737 BACKGROUND

• 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.

  PMID: 29362960 BACKGROUND

• 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.

  PMID: 29044337 BACKGROUND

• 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.

  PMID: 29608708 BACKGROUND

• 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.

  PMID: 29480025 BACKGROUND

• 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.

  PMID: 26715763 BACKGROUND

• 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.

  PMID: 26316654 BACKGROUND

• 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.

  PMID: 30550060 BACKGROUND

• 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.

  PMID: 24070232 BACKGROUND

• 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.

  PMID: 25213326 BACKGROUND

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking, patients and physicians will be aware of their study arm assignment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The investigators will recruit 25 patients who will receive the exercise plans and once weekly visits from the exercise physiologists. 25 patients will be control. All 50 patients will receive pre and post physical function testing.

Study Record Dates

• First Submitted: February 12, 2019
• First Posted: May 10, 2019
• Study Start: February 22, 2019
• Primary Completion: July 10, 2019
• Study Completion: July 17, 2019
• Last Updated: September 23, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)