Home-based vs Intradialysis Exercise Guided by Nursing Staff

End Stage Renal Disease on Dialysis Clinical Trial

— HoBIDnurse  

Official title:

Home-based vs Intradialysis Exercise Program Guided by Nursing Staff

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04051515
• Other study ID #: HoBIDnurse
• Status: Completed
• Phase: N/A
• Start date: August 9, 2019
• Est. completion date: November 29, 2019

Study information

• Verified date: January 2021
• Source: Cardenal Herrera University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: November 29, 2019
• Est. primary completion date: November 29, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• End Stage Renal Disease on Dialysis
• Kidney Failure, Chronic

Intervention

Other:
• Intradialysis exercise training
Combined exercise, aerobic and resistance training, implemented by nursing staff
• Home-based exercise training
Combined exercise, aerobic and resistance training, implemented independently home

Locations

Country	Name	City	State
Belgium	KU Leuven	Leuven
Greece	Aristotle University of Thessaloniki	Thessaloníki
Spain	Hospital de Manises	Manises	Valencia
Spain	Universiat de Valéncia	Valencia
Spain	Universitat de Valencia	Valencia
Sweden	Skane Univeristy Hospital	Lund
Sweden	Karolinska Institute	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Cardenal Herrera University	Hospital de Manises

Countries where clinical trial is conducted

Belgium,  Greece,  Spain,  Sweden, 

References & Publications (4)

Ortega-Pérez de Villar L, Martínez-Olmos FJ, Junqué-Jiménez A, Amer-Cuenca JJ, Martínez-Gramage J, Mercer T, Segura-Ortí 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. — View 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. Review. — View Citation

Segura-Ortí E, Martínez-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. — View Citation

Segura-Ortí 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. Review. Spanish. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change from baseline gait speed at 16 weeks	Speed to cover 4 meters, in meters/second	Baseline, 16 weeks
Secondary	Change from baseline sit to stand 10 test at 16 weeks	Time to perform 10 repetitions sit to stand	Baseline, 16 weeks
Secondary	Change from baseline sit to stand 60 test at 16 weeks	Sit to stand repetitions performed in 60 seconds	Baseline, 16 weeks
Secondary	Change from baseline 6 minutes walk test at 16 weeks	Number of meters walked in 6 minutes	Baseline, 16 weeks
Secondary	Change from baseline handgrip strength at 16 weeks	Bilateral handgrip strength	Baseline, 16 weeks
Secondary	Change from baseline one-leg heel rise test at 16 weeks	Number of heel rise repetitions achieved	Baseline, 16 weeks
Secondary	Change from baseline one-leg standing test at 16 weeks	Time achieved while standing on one leg	Baseline, 16 weeks
Secondary	Change from baseline timed up and go test at 16 weeks	Time to stand up, walk 3 meters, come back and sit down again	Baseline, 16 weeks
Secondary	Change from baseline Physical activity level at 16 weeks	Physical activity questionnaires	Baseline, 16 weeks
Secondary	Change from baseline Health related quality of life at 16 weeks	Medical outcomes survey Short Form 36 questionnaire to measure health-related quality of life, rated from 0 to 100, being the highest score the better the quality of life	Baseline, 16 weeks
Secondary	Adherence, as number of sessions performed /number of sessions offered	Sessions performed/sessions offered	16 weeks