EXerCise Introduction To Enhance Performance in Dialysis(EXCITE)

NCT01255969 | Completed Phase 4 DMC

• 1 other identifier: EXCITE-001
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate if a model of intervention based on a low-grade physical program prescribed in the dialysis centre and performed at home can modify the functional capacity and quality of life, reduce the risk of cardiovascular and all-causes mortality, non-fatal cardiovascular events and vascular access failure in dialysis patients.

Conditions

Patients on Dialysis (Hemodialysis, Peritoneal Dialysis)

Keywords

Dialysis; Physical exercise; Clinical Trial; Quality of Life; Performance; Fitness; Cardiovascular Mortality; Vascular access

Outcome Measures

Primary Outcomes (2)

• Assessment of Quality of Life (QoL) modification by the KIDNEY DISEASE QUALITY OF LIFE (KDQOL)questionary

  6 months is the time frame for the primary analysis but the follow-up will continue until 3 years.

  6 months

• Assessment of functional capacity by Six-Minute Walking test and Sit-to-Stand-to-sit test

  6 months is the time frame for the primary analysis but the follow-up will continue until 3 years.

  6 months

Secondary Outcomes (2)

• Evaluation of mortality (all causes and cardiovascular only), non-fatal cardiovascular events, all-causes hospitalizations and dialysis access survival.

  6 months

• All - causes and cardiovascular hospitalizations

  6 months

Study Arms (2)

Control

NO INTERVENTION

Exercise

EXPERIMENTAL

Patients in this arm will undergo to personalized exercise program.

Other: Exercise

Interventions

Exercise OTHER

Personalized exercise program

Exercise

Eligibility Criteria

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

You may qualify if:

• Patients on dialysis
• Dialysis vintage\>6 mo.
• Age\>18 aa.
• Signed informed consent
• Stable clinical conditions

You may not qualify if:

• any physical or clinical limitations to deambulation

Sponsors & Collaborators

• Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy: lead

Study Sites (1)

Dialysis Units participating to the EXCITE study in Italy

Reggio Calabria, Italy

Location

Related Publications (9)

• Mallamaci F, Tripepi G, Cutrupi S, Malatino LS, Zoccali C. Prognostic value of combined use of biomarkers of inflammation, endothelial dysfunction, and myocardiopathy in patients with ESRD. Kidney Int. 2005 Jun;67(6):2330-7. doi: 10.1111/j.1523-1755.2005.00338.x.

  PMID: 15882276 BACKGROUND

• Kutner NG, Zhang R, Huang Y, Herzog CA. Cardiac rehabilitation and survival of dialysis patients after coronary bypass. J Am Soc Nephrol. 2006 Apr;17(4):1175-80. doi: 10.1681/ASN.2005101027. Epub 2006 Feb 15.

  PMID: 16481413 BACKGROUND

• Malagoni AM, Catizone L, Mandini S, Soffritti S, Manfredini R, Boari B, Russo G, Basaglia N, Zamboni P, Manfredini F. Acute and long-term effects of an exercise program for dialysis patients prescribed in hospital and performed at home. J Nephrol. 2008 Nov-Dec;21(6):871-8.

  PMID: 19034871 BACKGROUND

• Mallamaci F, Bratsiakou A, D'Arrigo G, Tripepi G, Lamberti N, Torino C, Manfredini F, Zoccali C. Sex Differences in the EXerCise Introduction to Enhance Performance in Dialysis Trial. Clin J Am Soc Nephrol. 2025 Jun 13;20(8):1072-1078. doi: 10.2215/CJN.0000000759.

  PMID: 40512565 DERIVED

• Mallamaci F, D'Arrigo G, Tripepi G, Lamberti N, Torino C, Manfredini F, Zoccali C. Long-Term Effect of Physical Exercise on the Risk for Hospitalization and Death in Dialysis Patients: A Post-Trial Long-Term Observational Study. Clin J Am Soc Nephrol. 2022 Aug;17(8):1176-1182. doi: 10.2215/CJN.03160322. Epub 2022 Jul 25.

  PMID: 35878932 DERIVED

• Bernier-Jean A, Beruni NA, Bondonno NP, Williams G, Teixeira-Pinto A, Craig JC, Wong G. Exercise training for adults undergoing maintenance dialysis. Cochrane Database Syst Rev. 2022 Jan 12;1(1):CD014653. doi: 10.1002/14651858.CD014653.

  PMID: 35018639 DERIVED

• Baggetta R, D'Arrigo G, Torino C, ElHafeez SA, Manfredini F, Mallamaci F, Zoccali C, Tripepi G; EXCITE Working group. Effect of a home based, low intensity, physical exercise program in older adults dialysis patients: a secondary analysis of the EXCITE trial. BMC Geriatr. 2018 Oct 20;18(1):248. doi: 10.1186/s12877-018-0938-5.

  PMID: 30342464 DERIVED

• Manfredini F, Lamberti N, Malagoni AM, Felisatti M, Zuccala A, Torino C, Tripepi G, Catizone L, Mallamaci F, Zoccali C. The role of deconditioning in the end-stage renal disease myopathy: physical exercise improves altered resting muscle oxygen consumption. Am J Nephrol. 2015;41(4-5):329-36. doi: 10.1159/000431339. Epub 2015 Jun 11.

  PMID: 26067552 DERIVED

• Torino C, Manfredini F, Bolignano D, Aucella F, Baggetta R, Barilla A, Battaglia Y, Bertoli S, Bonanno G, Castellino P, Ciurlino D, Cupisti A, D'Arrigo G, De Paola L, Fabrizi F, Fatuzzo P, Fuiano G, Lombardi L, Lucisano G, Messa P, Rapana R, Rapisarda F, Rastelli S, Rocca-Rey L, Summaria C, Zuccala A, Tripepi G, Catizone L, Zoccali C, Mallamaci F; EXCITE Working Group. Physical performance and clinical outcomes in dialysis patients: a secondary analysis of the EXCITE trial. Kidney Blood Press Res. 2014;39(2-3):205-11. doi: 10.1159/000355798. Epub 2014 Jul 29.

  PMID: 25118076 DERIVED

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Carmine Zoccali, Prof.

  CNR-IBIM and Nephrology Unit, Reggio Calabria

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof.

Study Record Dates

• First Submitted: December 7, 2010
• First Posted: December 8, 2010
• Study Start: April 1, 2010
• Primary Completion: February 1, 2014
• Study Completion: July 1, 2015
• Last Updated: August 4, 2016

Record last verified: 2016-08

Locations

IT (1)