Home-based vs Intradialysis Exercise Guided by Nursing Staff

NCT04051515 | Completed

• 1 other identifier: HoBIDnurse
• Study Type: interventional
• Target: 70
• Locations: 4 countries
• Sites: 7

Brief Summary

Participants will be randomized either to home-based exercise or to intradialysis exercise guided by nurses of the renal unit. The programs will last 16 weeks. The intradialysis exercise consists of combined aerobic and resistance training exercise. The home-based exercise consists of resistance exercise and walking.

Conditions

End Stage Renal Disease on Dialysis

Keywords

Exercise; Hemodialysis

Outcome Measures

Primary Outcomes (2)

• Change from baseline short physical performance battery at 16 weeks

  Score achieved at the battery that includes balance tests (4 points), sit to stand to sit 5 (4 points) and and gait speed (4 points). The total score is calculated , from 1 to 12, being 12 the highest functional score

  Baseline, 16 weeks

• Change from baseline gait speed at 16 weeks

  Speed to cover 4 meters, in meters/second

  Baseline, 16 weeks

Secondary Outcomes (10)

• Change from baseline sit to stand 10 test at 16 weeks

  Baseline, 16 weeks

• Change from baseline sit to stand 60 test at 16 weeks

  Baseline, 16 weeks

• Change from baseline 6 minutes walk test at 16 weeks

  Baseline, 16 weeks

• Change from baseline handgrip strength at 16 weeks

  Baseline, 16 weeks

• Change from baseline one-leg heel rise test at 16 weeks

  Baseline, 16 weeks

Study Arms (2)

Intradialysis exercise guided by nursing staff

EXPERIMENTAL

During 16 weeks subjects will exercise during the hemodialysis session, the exercise will include both aerobic and resistance training. Guidance will be provided by nursing staff

Other: Intradialysis exercise training

Home-based exercise program

ACTIVE COMPARATOR

During 16 weeks subjects will exercise on their own at home. A booklet will be provided, with a diary. Instructions to do resistance exercise with intervals of walking will be provided. Initial training will be provided by physiotherapy staff from the hospital.

Other: Home-based exercise training

Interventions

Intradialysis exercise training OTHER

Combined exercise, aerobic and resistance training, implemented by nursing staff

Intradialysis exercise guided by nursing staff

Home-based exercise training OTHER

Combined exercise, aerobic and resistance training, implemented independently home

Home-based exercise program

Eligibility Criteria

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

You may qualify if:

• Patients on hemodialysis medically stable, be able to walk at least a few steps, even if you need walking aids like canes or a walker. Life expectancy greater than 6 months

You may not qualify if:

• Myocardial infarction in the previous 6 weeks
• Angina unstable on exercise or at rest
• Brain injury derived from a cardiovascular problem. Cerebral vascular disease such as stroke in the last 6 months or with relevant sequelae in lower limb mobility presenting hemiparesia.
• Life expectancy less than 6 months
• Cognitive impairment
• Language barriers
• Illiteracy

Sponsors & Collaborators

• Cardenal Herrera University: lead
• Hospital de Manises: collaborator

Study Sites (7)

KU Leuven

Leuven, 3000, Belgium

Location

Aristotle University of Thessaloniki

Thessaloniki, 57001, Greece

Location

Hospital de Manises

Manises, Valencia, 46940, Spain

Location

Universitat de Valencia

Valencia, 46010, Spain

Location

Universiat de Valéncia

Valencia, 46022, Spain

Location

Skane Univeristy Hospital

Lund, Sweden

Location

Karolinska Institute

Stockholm, 14186, Sweden

Location

Related Publications (4)

• Segura-Orti E, Martinez-Olmos FJ. Test-retest reliability and minimal detectable change scores for sit-to-stand-to-sit tests, the six-minute walk test, the one-leg heel-rise test, and handgrip strength in people undergoing hemodialysis. Phys Ther. 2011 Aug;91(8):1244-52. doi: 10.2522/ptj.20100141. Epub 2011 Jun 30.

  PMID: 21719637 BACKGROUND

• Segura-Orti E, Johansen KL. Exercise in end-stage renal disease. Semin Dial. 2010 Jul-Aug;23(4):422-30. doi: 10.1111/j.1525-139X.2010.00766.x.

  PMID: 20701722 BACKGROUND

• Segura-Orti E. [Exercise in haemodyalisis patients: a literature systematic review]. Nefrologia. 2010;30(2):236-46. doi: 10.3265/Nefrologia.pre2010.Jan.10229. Epub 2010 Jan 21. Spanish.

  PMID: 20098466 BACKGROUND

• Ortega-Perez de Villar L, Martinez-Olmos FJ, Junque-Jimenez A, Amer-Cuenca JJ, Martinez-Gramage J, Mercer T, Segura-Orti E. Test-retest reliability and minimal detectable change scores for the short physical performance battery, one-legged standing test and timed up and go test in patients undergoing hemodialysis. PLoS One. 2018 Aug 22;13(8):e0201035. doi: 10.1371/journal.pone.0201035. eCollection 2018.

  PMID: 30133445 BACKGROUND

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Eva Segura-Ortí, PhD

  Universidad CEU Cardenal Herrera, UCH CEU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: A team of assessors, different from the researchers implementing the exercise, will record all dependent variables. A blind researcher will randomize participants
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants will be randomized into one of two exercise groups, intradialysis or home-based program

Study Record Dates

• First Submitted: August 7, 2019
• First Posted: August 9, 2019
• Study Start: August 9, 2019
• Primary Completion: November 29, 2019
• Study Completion: November 29, 2019
• Last Updated: January 29, 2021

Record last verified: 2021-01

Locations

BE (1); GR (1); SE (2); ES (3)