End Stage Renal Disease on Dialysis Clinical Trial
— HoBIDnurseOfficial title:
Home-based vs Intradialysis Exercise Program Guided by Nursing Staff
Verified date | January 2021 |
Source | Cardenal Herrera University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Cardenal Herrera University | Hospital de Manises |
Belgium, Greece, Spain, Sweden,
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
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 |
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