Aerobic Exercise
OtherEX: 30 min of aerobic exercise (3/10 Borg scale) during hemodialysis treatment (between 30 min and 3h of treatment).
Completed
NCT Number: 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
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.
Completed
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Notify MeKey information
Conditions
Age range
60 year–85 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
CIUSSS de l'Estrie - CHUS, Sherbrooke, Quebec, Canada
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Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Control
OtherCONT: participants will receive hemodialysis treatment only (usual care)
Primary outcomes
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Change in blood pressure
Time frame: 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.
Measured using standard clinical procedures (Automatic Blood Pressure Monitor at rest and with aneroid sphygmomanometer during and after exercise)
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Change in perceived fatigue
Time frame: 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).
10-centimeter horizontal visual analog scale, going from no fatigue (left) to extreme fatigue (right)
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Change in perceived sleepiness
Time frame: 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).
10-centimeter horizontal visual analog scale, going from no sleepiness (left) to extreme sleepiness (right)
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Change in mood
Time frame: 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).
10-centimeter horizontal visual analog scale, going from very bad (left) to very good (right)
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Change in perceived soreness
Time frame: 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).
10-centimeter horizontal visual analog scale, going from no soreness (left) to extreme soreness (right)
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Change in perceived sleep quality
Time frame: Measured at 10:00 am the day following the experimental condition.
10-centimeter horizontal visual analog scale, going from very bad (left) to extreme soreness (right)
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Plasma Metabolome and proteome at the end of the experimental (exercise) condition
Time frame: After 30 minutes of exercise
A blood draw will be realized immediately at the end of the dialysis session comprising the exercise condition. The plasma metabolome and proteome will be determined using mass spectrometry.
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Plasma Metabolome and proteome at the end of the control (rest) condition
Time frame: After 30 minutes of rest
A blood draw will be realized immediately at the end of the dialysis session representing the control condition. The plasma metabolome and proteome will be determined using mass spectrometry.
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Single pool Kt/V, experimental (exercise) condition
Time frame: After 4 hours of dialysis
measured using standard clinical procedures (blood draw before and at the end of the dialysis session comprising the exercise condition, by a research nurse).
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Single pool Kt/V, control (rest) condition
Time frame: After 4 hours of dialysis
measured using standard clinical procedures (blood draw before and at the end of the dialysis session representing the condition, by a research nurse).
Secondary outcomes
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Hematocrit (%)
Time frame: Extracted from each patient's medical record at inclusion.
Routinely measured (monthly) as standard clinical practice, before a dialysis session.
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Hemoglobin (g/L)
Time frame: Extracted from each patient's medical record at inclusion.
Routinely measured (monthly) as standard clinical practice, before a dialysis session.
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Red blood cells count (10^12/L)
Time frame: Extracted from each patient's medical record at inclusion.
Routinely measured (monthly) as standard clinical practice, before a dialysis session.
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White blood cells count (10^9/L)
Time frame: Extracted from each patient's medical record at inclusion.
Routinely measured (monthly) as standard clinical practice, before a dialysis session.
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Platelets count (10^9/L)
Time frame: Extracted from each patient's medical record at inclusion.
Routinely measured (monthly) as standard clinical practice, before a dialysis session.
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Red blood cell mean corpuscular hemoglobin (pg)
Time frame: Extracted from each patient's medical record at inclusion.
Routinely measured (monthly) as standard clinical practice, before a dialysis session.
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Red blood cell mean corpuscular volume (fL)
Time frame: Extracted from each patient's medical record at inclusion.
Routinely measured (monthly) as standard clinical practice, before a dialysis session.
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Red blood cell distribution width (%)
Time frame: Extracted from each patient's medical record at inclusion.
Routinely measured (monthly) as standard clinical practice, before a dialysis session.
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Plasma sodium (mmol/L)
Time frame: Extracted from each patient's medical record at inclusion.
Routinely measured (monthly) as standard clinical practice, before a dialysis session.
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Plasma potassium (mmol/L)
Time frame: Extracted from each patient's medical record at inclusion.
Routinely measured (monthly) as standard clinical practice, before a dialysis session.
-
Plasma calcium (mmol/L)
Time frame: Extracted from each patient's medical record at inclusion.
Routinely measured (monthly) as standard clinical practice, before a dialysis session.
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Plasma phosphate (mmol/L)
Time frame: Extracted from each patient's medical record at inclusion.
Routinely measured (monthly) as standard clinical practice, before a dialysis session.
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Plasma glucose (mmol/L)
Time frame: Extracted from each patient's medical record at inclusion.
Routinely measured (monthly) as standard clinical practice, before a dialysis session.
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Plasma creatinine (mmol/L)
Time frame: Extracted from each patient's medical record at inclusion.
Routinely measured (monthly) as standard clinical practice, before a dialysis session.
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Health-Related Quality of Life
Time frame: Once, at the beginning of the dialysis session comprising the first condition
French version of the Kidney Disease Quality of Life 36 items version 1.3 (KDQOL-36)
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Disease-related symptoms
Time frame: Twice, seven days after each experimental conditions
The French version of the Dialysis Symptom Index, consisting in a seven-day recall questionnaire assessing the presence and intensity of 30 symptoms
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Physical activity scale for the Elderly (PASE) questionnaire
Time frame: Once, at the beginning of the dialysis session comprising the first condition
Recall questionnaire of the previous week's leisure, occupational and domestic physical activity habits validated in older adults.
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Estimated daily energy expenditure
Time frame: The watch will be worn during the 24 hours following each experimental condition
Wrist-worn accelerometer (Apple Watch)
Sponsors and collaborators
Lead sponsor
Université de Sherbrooke
Other
Collaborators
- Estrie University Integrated Health and Social Services Center - University Hospital of Sherbrooke
Registry information
Official study 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
Acronym: CPExA
Important dates
- Study start
- 2022
- Primary completion
- 2022
- Study completion
- 2022
- First posted
- Jun 3, 2022
- Registry last updated
- Nov 3, 2022
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.