Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Hospital de Manises | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intradialysis exercise training | Other | Combined exercise, aerobic and resistance training, implemented by nursing staff |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline sit to stand 10 test at 16 weeks | Time to perform 10 repetitions sit to stand | Baseline, 16 weeks |
| Change from baseline sit to stand 60 test at 16 weeks | Sit to stand repetitions performed in 60 seconds |
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Eva Segura-OrtĂ, PhD | Universidad CEU Cardenal Herrera, UCH CEU | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KU Leuven | Leuven | 3000 | Belgium | |||
| Aristotle University of Thessaloniki |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21719637 | Background | 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. | |
| 20701722 | Background |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
Not provided
Not provided
Participants will be randomized into one of two exercise groups, intradialysis or home-based program
Not provided
Not provided
A team of assessors, different from the researchers implementing the exercise, will record all dependent variables. A blind researcher will randomize participants
| Home-based exercise training | Other | Combined exercise, aerobic and resistance training, implemented independently home |
|
| Baseline, 16 weeks |
| Change from baseline 6 minutes walk test at 16 weeks | Number of meters walked in 6 minutes | Baseline, 16 weeks |
| Change from baseline handgrip strength at 16 weeks | Bilateral handgrip strength | Baseline, 16 weeks |
| Change from baseline one-leg heel rise test at 16 weeks | Number of heel rise repetitions achieved | Baseline, 16 weeks |
| Change from baseline one-leg standing test at 16 weeks | Time achieved while standing on one leg | Baseline, 16 weeks |
| 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 |
| Change from baseline Physical activity level at 16 weeks | Physical activity questionnaires | Baseline, 16 weeks |
| 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 |
| Adherence, as number of sessions performed /number of sessions offered | Sessions performed/sessions offered | 16 weeks |
| Thessaloniki |
| 57001 |
| Greece |
| Hospital de Manises | Manises | Valencia | 46940 | Spain |
| Universitat de Valencia | Valencia | 46010 | Spain |
| Universiat de Valéncia | Valencia | 46022 | Spain |
| Skane Univeristy Hospital | Lund | Sweden |
| Karolinska Institute | Stockholm | 14186 | Sweden |
| 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. |
| 20098466 | 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. |
| 30133445 | 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. |