Chronic Kidney Diseases Clinical Trial
— GoodRENalOfficial title:
REVID +: Integrated Patient Care Intradialysis Programme in Hemodialysis Through a Virtual Health Platform (GoodRENal.eu)
There is wide evidence regarding the weak points of end-stage Chronic kidney disease (CKD) patients in hemodialysis, and they include three intervention aspects: exercise, nutrition and psychological support. Evidence shows that exercise for patients in hemodialysis results in increased survival rate, functional capacity, strength and health-related quality of life. Additionally, different studies have shown the benefits of psychological interventions and the positive effect of educational programs on nutritional care for patients in hemodialysis. Despite the well-known benefits of exercise, this kind of programs are not being implemented in the routine clinical care of hemodialysis patients. Thus, the GoodRENal project aims to promote healthy lifestyles among dialysis patients in a holistic approach that combines exercise, nutrition and psychological wellbeing plus cognitive functioning addressing adult learners. The project will, in phase 1, explore barriers and facilitators of patients, carers and health professionals towards healthy lifestyle (physical activity, nutrition and psychological well being). In phase 2, the project will develop a health virtual platform including these three dimensions of cares. In summary, the project outputs will be: 1. A didactic content in a modular platform to create an educational program for integrated treatments in patients with dialysis 2. A guideline to promote healthy lifestyles among dialysis patients for health care providers 3. A guideline to promote e healthy lifestyles among dialysis patients for patients and formal - nonformal carers
Status | Recruiting |
Enrollment | 70 |
Est. completion date | August 31, 2024 |
Est. primary completion date | July 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | Inclusion Criteria: - Patients on hemodialysis medically stable - Ability to walk to walk at least a few steps, even if walking aids like canes or a walker ar needed - Life expectancy greater than 6 months Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Belgium | KU Leuven | Leuven | |
Greece | Aristotle University of Thessaloniki | Thessaloníki | |
Spain | Hospital de Manises | Manises | Valencia |
Spain | Consorci Sanitari de Terrassa | Terrassa | Barcelona |
Spain | Universitat de Valencia | Valencia | |
Spain | Universitat Politécnica de Valéncia | Valencia | |
Sweden | Skane Univeristy Hospital | Lund | |
Sweden | Karolinska Institute | Stockholm |
Lead Sponsor | Collaborator |
---|---|
Cardenal Herrera University | Aristotle University Of Thessaloniki, Hospital de Manises, Karolinska Institutet, KU Leuven, Skane University Hospital, Universitat Politècnica de València, University of Valencia |
Belgium, Greece, Spain, Sweden,
Segura-Orti E, Gordon PL, Doyle JW, Johansen KL. Correlates of Physical Functioning and Performance Across the Spectrum of Kidney Function. Clin Nurs Res. 2018 Jun;27(5):579-596. doi: 10.1177/1054773816689282. Epub 2017 Jan 23. — 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. — View Citation
Segura-Orti E, Kouidi E, Lison JF. Effect of resistance exercise during hemodialysis on physical function and quality of life: randomized controlled trial. Clin Nephrol. 2009 May;71(5):527-37. doi: 10.5414/cnp71527. — View 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. — View Citation
Segura-Orti E, Rodilla-Alama V, Lison JF. [Physiotherapy during hemodialysis: results of a progressive resistance-training programme]. Nefrologia. 2008;28(1):67-72. Spanish. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline distance walked assessed by the 6 minutes walk test at 12 weeks | More meters walked in 6 minutes mean a better walking capacity | Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention | |
Secondary | Change from baseline health-related quality of life assessed by the Short Form 36 questionnaire at 12 weeks | The short form 36 gives data on 8 subscales and 2 components, higher score mean better health-related quality of life The scores range from 0 to 100, with 100 indicating optimal health and 0 reflecting very poor health. | Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention | |
Secondary | Change from baseline stance from a chair capacity assessed by the sit to stand 10 at 12 weeks | Time in seconds to perform 10 sit to stand repetitions. A decrease in the time to perform the test means better functional capacity to stand up from a chair | Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention | |
Secondary | Change from baseline usual gait speed assessed by a 4 meters gait speed test at 12 weeks | Speed in m/s to cover 4 meters at normal speed. An increase in speed to perform the test means better gait speed | Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention | |
Secondary | Change from baseline handgrip strength assessed by a handgrip dinamometer at 12 weeks | Bilateral handgrip strength measured in kilograms. An increase in handgrip strength means better strength | Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention | |
Secondary | Change from baseline lower limbs strength assessed by a dinamometer at 12 weeks | Bilateral lower limbs muscle strength measured in kilograms. An increase in strength means better strength | Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention | |
Secondary | Change from baseline physical activity level assessed by the human activity profile questionnaire, average activity score at 12 weeks | The average activity score of the human activity profile questionnaire ranges from 0 to 94. . A higher score means a higher physical activity level | Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention | |
Secondary | Change from baseline physical activity level assessed by the international physical activity questionnaire at 12 weeks | The score of the international physical activity questionnaire will be recorded in MET-minutes/week. A higher score means a higher physical activity level | Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention | |
Secondary | Percentage of sessions performed from te sessions offered to measure adherence to the educational program | Calculation will be the result of sessions performed/sessions offered | After 12 weeks of intervention | |
Secondary | Healthcare resources expenditure and costs | Total amount in euros spent on external consultations, laboratory tests, radiology tests, hospital pharmacy, emergency department healthcare provision, and hospitalisation. | Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention | |
Secondary | Change from baseline lean body mass assessed by the bioimpedance spectroscopy at 12 weeks | Lean body mass is a surrogate of muscle mass in kilograms. Increase in lean body mass means increase in muscle mass | Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention | |
Secondary | Change from baseline qualitative assessment in food intake assessed by the Short form food questionnaire at 12 weeks | Qualitative assessment of food intake Short form food questionnaire. Improvement in the dietary quality | Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention | |
Secondary | Change from baseline nutritional status assessed by the 7 point Subjective Global Assessment at 12 weeks | 7 point subjective global assessment scores from 1 to 7, the higher the score the better nutritional status | Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention | |
Secondary | Change from baseline cognitive function assessed by the Mini-mental State at 12 weeks | The maximum MMSE score is 30 points. A score of 20 to 24 suggests mild dementia, 13 to 20 suggests moderate dementia, and less than 12 indicates severe dementia. | Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention | |
Secondary | Change from baseline Anxiety assessed by the Hospital Anxiety and Depression Scale at 12 weeks | Scores obtained between 0 and 21. The higher the score obtained, the higher the level of anxiety and depression. | Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention | |
Secondary | Change from baseline positive and negative emotions assessed by Positive and Negative Affect Schedule Scale (PANAS) at 12 weeks | It includes 2 subscales (positive affect and negative affect) with 10 items each. Each subscale can contain scores between 10 and 50. The higher the score obtained, the greater the presence of a particular affect. | Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention | |
Secondary | Change from baseline depression assessed by the Beck Depression Inventory (BDI) at 12 weeks | The scores range from 0 to 63 points. The higher the score, the greater the severity of depressive symptoms. Four groups are established according to the total score: 0-13, minimal depression; 14-19, mild depression; 20-28, moderate depression; and 29-63, severe depression. | Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention | |
Secondary | Change from baseline anxiety assessed by the State Trait Anxiety Inventory (STAI) at 12 weeks | Scale composed of 2 subscales. The range of scores for both subscales is between 0 and 60 points so that higher scores reflect greater anxiety. | Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention | |
Secondary | Change from baseline perceived stress assessed by the Perceived Stress Scale (PSS) at 12 weeks | Scores obtained in a range of 0 to 56 points. The higher the score obtained, the higher the level of perceived stress. | Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention | |
Secondary | Change from baseline cognitive state assessed by the Montreal Cognitive Assessment (MoCA)at 12 weeks | Scores on the MoCA assessment range from 0 to 30. A score of 26 and above is considered normal. | Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention | |
Secondary | Change from baseline attention level assessed by the Trail Making Test (TMT) at 12 weeks | Scoring is based on time taken to complete the test, with lower scores being better. | Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention | |
Secondary | Change from baseline memory assessed by the Wechsler-IV Memory Scale at 12 weeks | The correction system allows obtaining scalar scores, indices, centiles and confidence intervals, in order to achieve a more flexible interpretation. It is interpreted on the basis of scales. The Spanish scales have been elaborated from a sample of almost 900 subjects aged between16 and 90 years. | Baseline, after 12 weeks of intervention, 12 weeks follow-up after the end of the intervention |
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