Clinical trial NCT05404698: Molecular and Clinical Response to a Single Bout of Aerobic Exercise in a Multimorbid Population: a Study From the Consortium on Precision EXercise in Aging
Official title: Integration of Multi-omics, Health Profile, Patient-related Outcomes and Exercise Data to Improve and Personalize Health Care in Hospital Settings: A CPExA Proof of Concept
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multimorbidity - End-stage Kidney Disease
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
Collaborators: name: Estrie University Integrated Health and Social Services Center - University Hospital of Sherbrooke
First posted: 2022-06-03
Enrollment: 10
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Each participant performed 2 experimental conditions (rest, moderate continuous aerobic exercise with our cycle ergometer prototype - EXALT).
Primary purpose: SUPPORTIVE_CARE

Brief summary: The combination of data from different origins (biological, health, patient-related) has the potential to improve care for the elderly. Precision approaches that are emerging in health are based on the premise that a better understanding of the biological responses to interventions will make it possible to optimize the treatments. In the field of exercise, this type of approach is emerging. This pilot study aims to collect preliminary data to demonstrate that a patient-centric vision with data from multiple sources is mandatory to personalize exercise intervention and improve health care. Older adults with end-stage chronic disease treated by hemodialysis represent a population of choice that requires personalized care since they are multimorbid and exhibit a complex health profile.

On the other hand, the beneficial effects of exercise are still little understood and the avoidance of adverse effects in response to exercise such as hypotension during dialysis remains uninvestigated.Objective: Demonstrate the feasibility of an integrative approach by combining "omics", clinical data, patient-related outcomes (PRO) as well as exercise variables (e.g., intensity, duration) Methods: A total of 10 people aged 60 and over will be recruited to randomly perform 2 experimental conditions: hemodialysis alone (CONT) or hemodialysis + aerobic exercise (EX), which will be carried out over 2 visits one week apart. These visits will take place at the scheduled time of the hemodialysis treatment. The variables of interest are: blood pressure response to a single bout of exercise exercise (during and post-exercise), symptoms (with visual analogue scales within 36 hours of the visit + Dialysis symptom index for the 7 days after the experimental visit), dialysis efficiency (Kt/V) and biological response (proteomics and metabolomics). Health-related quality of life (KDQOL questionnaire), medical data (electronic medical record), and level of physical activity (PASE questionnaire and smart watch; Apple Watch) will be evaluated.


Eligibility criteria: Inclusion Criteria:

* being treated by hemodialysis for end-stage kidney disease for at least 3 months
* medically eligible

Exclusion Criteria:

* diagnosed neurocognitive decline
* hip fracture with recent hemiarthroplasty preventing hip flexion while pedalling,
* COVID-19 positive,
* already included in another study.

Primary outcomes:
measure: Change in blood pressure
timeFrame: Before and after the condition as well as every 5 minutes during the 20 minutes after (10 measurements). After this time frame, each 30 minutes up to the end of the dialysis session.
measure: Change in perceived fatigue
timeFrame: Measured at 2:00 pm and 6:00 pm the day of the experimental condition and at 10:00 am, 2:00 pm and 6:00 pm the day following the experimental condition (for a total of 24 hours).
measure: Change in perceived sleepiness
timeFrame: Measured at 2:00 pm and 6:00 pm the day of the experimental condition and at 10:00 am, 2:00 pm and 6:00 pm the day following the experimental condition (for a total of 24 hours).
measure: Change in mood
timeFrame: Measured at 2:00 pm and 6:00 pm the day of the experimental condition and at 10:00 am, 2:00 pm and 6:00 pm the day following the experimental condition (for a total of 24 hours).
measure: Change in perceived soreness
timeFrame: Measured at 2:00 pm and 6:00 pm the day of the experimental condition and at 10:00 am, 2:00 pm and 6:00 pm the day following the experimental condition (for a total of 24 hours).
measure: Change in perceived sleep quality
timeFrame: Measured at 10:00 am the day following the experimental condition.
measure: Plasma Metabolome and proteome at the end of the experimental (exercise) condition
timeFrame: After 30 minutes of exercise
measure: Plasma Metabolome and proteome at the end of the control (rest) condition
timeFrame: After 30 minutes of rest
measure: Single pool Kt/V, experimental (exercise) condition
timeFrame: After 4 hours of dialysis
measure: Single pool Kt/V, control (rest) condition
timeFrame: After 4 hours of dialysis
Secondary outcomes:
measure: Hematocrit (%)
timeFrame: Extracted from each patient's medical record at inclusion.
measure: Hemoglobin (g/L)
timeFrame: Extracted from each patient's medical record at inclusion.
measure: Red blood cells count (10^12/L)
timeFrame: Extracted from each patient's medical record at inclusion.
measure: White blood cells count (10^9/L)
timeFrame: Extracted from each patient's medical record at inclusion.
measure: Platelets count (10^9/L)
timeFrame: Extracted from each patient's medical record at inclusion.
measure: Red blood cell mean corpuscular hemoglobin (pg)
timeFrame: Extracted from each patient's medical record at inclusion.
measure: Red blood cell mean corpuscular volume (fL)
timeFrame: Extracted from each patient's medical record at inclusion.
measure: Red blood cell distribution width (%)
timeFrame: Extracted from each patient's medical record at inclusion.
measure: Plasma sodium (mmol/L)
timeFrame: Extracted from each patient's medical record at inclusion.
measure: Plasma potassium (mmol/L)
timeFrame: Extracted from each patient's medical record at inclusion.
measure: Plasma calcium (mmol/L)
timeFrame: Extracted from each patient's medical record at inclusion.
measure: Plasma phosphate (mmol/L)
timeFrame: Extracted from each patient's medical record at inclusion.
measure: Plasma glucose (mmol/L)
timeFrame: Extracted from each patient's medical record at inclusion.
measure: Plasma creatinine (mmol/L)
timeFrame: Extracted from each patient's medical record at inclusion.
measure: Health-Related Quality of Life
timeFrame: Once, at the beginning of the dialysis session comprising the first condition
measure: Disease-related symptoms
timeFrame: Twice, seven days after each experimental conditions
measure: Physical activity scale for the Elderly (PASE) questionnaire
timeFrame: Once, at the beginning of the dialysis session comprising the first condition
measure: Estimated daily energy expenditure
timeFrame: The watch will be worn during the 24 hours following each experimental condition
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Centre de recherche sur le vieillissement
state: Quebec
city: Sherbrooke
country: Canada
facility: CIUSSS de l'Estrie - CHUS
state: Quebec
Study officials:
References: