Clinical trial NCT04051515: Home-based vs Intradialysis Exercise Guided by Nursing Staff
Official title: Home-based vs Intradialysis Exercise Program Guided by Nursing Staff
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End Stage Renal Disease on Dialysis
Keywords: Exercise
Hemodialysis
Lead sponsor: Cardenal Herrera University
Sponsor class: OTHER
Collaborators: name: Hospital de Manises
First posted: 2019-08-09
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized into one of two exercise groups, intradialysis or home-based program
Primary purpose: TREATMENT

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.

Detailed description: During 16 weeks one group will follow an intradialysis exercise program. The exercise program consists of strengthening exercises for lower limbs and for the upper limb free of fistula. The exercise program includes isotonic exercises for quadriceps, triceps surae, psoas, glutei, and brachial biceps; and isometric exercises for hip adductors and hamstrings. Elastic bands will be used to apply resistance. Progression will be achieved by increasing from 1 set of 10 repetitions until 3 sets of 15 repetitions. This first part of the exercise session will last no more than 30 minutes. The program will also include aerobic exercise (cycling) for up to 30 minutes. Intensity will adapted through the duration of the study so that the participant feel the exercise from hard to somewhat hard (13 to 15 at the rate of perceived exertion 6 to 20). Time and resistance will be adapted progressively. After an initial training period by a physiotherapist, the nursing staff will be responsible for monitoring and implementing the program.

The other group will follow a home-based program. A booklet with resistance exercise and recommendation of walking between exercises will be provided. An initial training phase will be applied by the physiotherapists from the rehabilitation department.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Myocardial infarction in the previous 6 weeks
2. Angina unstable on exercise or at rest
3. 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.
4. Life expectancy less than 6 months
5. Cognitive impairment
6. Language barriers
7. Illiteracy

Primary outcomes:
measure: Change from baseline short physical performance battery at 16 weeks
timeFrame: Baseline, 16 weeks
measure: Change from baseline gait speed at 16 weeks
timeFrame: Baseline, 16 weeks
Secondary outcomes:
measure: Change from baseline sit to stand 10 test at 16 weeks
timeFrame: Baseline, 16 weeks
measure: Change from baseline sit to stand 60 test at 16 weeks
timeFrame: Baseline, 16 weeks
measure: Change from baseline 6 minutes walk test at 16 weeks
timeFrame: Baseline, 16 weeks
measure: Change from baseline handgrip strength at 16 weeks
timeFrame: Baseline, 16 weeks
measure: Change from baseline one-leg heel rise test at 16 weeks
timeFrame: Baseline, 16 weeks
measure: Change from baseline one-leg standing test at 16 weeks
timeFrame: Baseline, 16 weeks
measure: Change from baseline timed up and go test at 16 weeks
timeFrame: Baseline, 16 weeks
measure: Change from baseline Physical activity level at 16 weeks
timeFrame: Baseline, 16 weeks
measure: Change from baseline Health related quality of life at 16 weeks
timeFrame: Baseline, 16 weeks
measure: Adherence, as number of sessions performed /number of sessions offered
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: KU Leuven
city: Thessaloníki
country: Greece
facility: Aristotle University of Thessaloniki
city: Manises
country: Spain
facility: Hospital de Manises
state: Valencia
city: Valencia
country: Spain
facility: Universitat de Valencia
city: Valencia
country: Spain
facility: Universiat de Valéncia
city: Lund
country: Sweden
facility: Skane Univeristy Hospital
city: Stockholm
country: Sweden
facility: Karolinska Institute
Study officials:
affiliation: Universidad CEU Cardenal Herrera, UCH CEU
name: Eva Segura-Ortí, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.