Category
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Primary study
Registry of Trials»ISRCTN registry
Year
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2017
INTERVENTION: Participants are randomised to one of the following three 8 week interventions through random number generation: HIIT programme A: Each session will consist of 16‐min interval training with intervals of 4, 2 and 1 min duration at 80%, progressing to 90% VO2peak over the 8 weeks, separated by a 2 min active rest ( 60% VO2peak) giving a total exercise time of 30 min. HIIT programme B: Each supervised session will consist of 4 x 4‐min of interval training at 80% VO2peak, progressing to 90% VO2peak over the 8 weeks, separated by a 3 min active rest ( 60% VO2peak) and with a final 5 recovery minute stage to ensure that overall work done is matched for both exercise protocols, therefore also giving a total exercise time of 30 min. MICT Exercise Intervention: Each supervised session will consist of continuous brisk cycling for 40 min with a target RPE of 12‐14 (somewhat hard). This is equivalent to 50‐60% VO2peak and will be matched for energy expenditure with the HIIT sessions. In all groups, participants take part in 24 supervised training sessions over 8 weeks (approximately 3 sessions per week) CONDITION: Specialty: Renal disorders, Primary sub‐specialty: Renal disorders; UKCRC code/ Disease: Renal and Urogenital/ Renal failure ; Urological and Genital Diseases ; Renal failure PRIMARY OUTCOME: 1. Recruitment rate is assessed by recording the percentage of eligible invited, percentage of invited approached and percentage of approached consented throughout the study; 2. Compliance rate is assessed through recording the percentage of sessions attended by participants throughout the study; 3. Retention/completion rate is assessed by recording the percentage of participants completing all elements of the study throughout the duration of the study INCLUSION CRITERIA: 1. Participant is willing and able to give informed consent for participation in the study 2. Male or female, aged 18 years or above 3. Diagnosed with CKD and are a kidney transplant recipient 4. Received kidney transplant > 12 weeks prior to entering the study SECONDARY OUTCOME: 1. Physical function is measured by the gait speed test, the sit‐to‐stand tests and the plantarflexion strength test at baseline, mid‐intervention, immediately post‐intervention and three months post‐intervention; 2. Heart function is measured using Non‐invasive cardiac output measures (NICOM) at baseline, mid‐intervention, immediately post‐intervention and three months post‐intervention; 3. Anthropometry is measured using standard measures at baseline, mid‐intervention, immediately post‐intervention and three months post‐intervention; 4. Body composition is measured using bioelectrical impedance analysis at baseline, mid‐intervention, immediately post‐intervention and three months post‐intervention; 5. Arterial stiffness is measured using pulse wave velocity at baseline, mid‐intervention, immediately post‐intervention and three months post‐intervention; 6. Oxygen saturation is measure using a pulse oximeter at baseline, mid‐intervention, immediately post‐intervention and three months post‐intervention; 7. Habitual physical activity is measured using an accelerometer at baseline and immediately post‐intervention; 8. Muscle Oxygen Saturation is measured using Near‐infrared spectroscopy (NIRS) between training weeks 1‐2 and between training weeks 7‐8; 9. VO2 Peak is measured using a cardiopulmonary exercise test at baseline and immediately post‐intervention; 10. Urine bacterial content is analysed from a urine sample at baseline, mid‐intervention and immediate post‐intervention; 11. Clinical parameters (co‐morbidities, medication, blood test results) will be taken from medical notes at baseline, mid‐intervention, immediately post‐intervention and three months post‐intervention; 12. Blood samples for markers of immune function and inflammation and CVD risk factors will be taken via venepuncture at baseline, mid‐intervention, immediately post‐intervention and three months post‐intervention; 13. Immune function and markers of inflammation will be assessed via saliva samples at baseline, mid‐intervention, immediately post‐intervention and three months post‐intervention; 14. Patient satisfaction will be measured by a Patient Satisfaction Questionnaire at the end of study involvement; 15. Acceptability and satisfaction will be assessed via interviews and focus groups at the end of study involvement; 16. Illness symptoms will be assessed via an Illness‐Symptom Questionnaire at each exercise training session; 17. Disease related symptoms will be measured via the Renal Patient Outcome Scale (POS‐S Tx) at baseline, mid‐intervention, immediately post‐intervention and three months post‐intervention; 18. Fatigue will be measured via the Fatigue Scale at baseline, mid‐intervention, immediately post‐intervention and three months post‐intervention; 19. Quality of life will be measured via the EuroQual (EQ5D) at baseline, mid‐intervention, immediately post‐intervention and three months post‐intervention; 20. Illness perception will be measured via the Illness Perception Questionnaire (IPQ‐R) at baseline, mid‐intervention, immediately post‐intervention and three months post‐intervention; 21. Functional capacity will be measured via the Duke Activity Status Index (DASI) at baseline, mid‐intervention, immediately post‐intervention and three months post‐intervention; 22. Pain will be measured via the Brief Pain Inventory (BPI) at baseline, mid‐intervention, immediately post‐intervention and three months post‐intervention; 23. Sleep quality will be measured via the Pittsburgh Sleep Quality Index (PSQI) at baseline, mid‐intervention, immediately post‐intervention and three months post‐intervention; 24. Sleepiness will be measured via the Epworth Sleepiness Scale (ESS) at baseline, mid‐intervention, immediately post‐intervention and three months post‐intervention
Epistemonikos ID: 9b1171e002bee4bdbb4aea0e2bc5c485a96dfaf5
First added on: Aug 23, 2024