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 (CPExA)
Primary Purpose
Multimorbidity - End-stage Kidney Disease
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Aerobic exercise
Control
Sponsored by
About this trial
This is an interventional supportive care trial for Multimorbidity - End-stage Kidney Disease
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.
Sites / Locations
- Centre de recherche sur le vieillissement
- CIUSSS de l'Estrie - CHUS
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Aerobic intradialytic exercise
Standard care
Arm Description
10 patients will perform Aerobic exercise with the cycle ergometer prototype (EXALT) during hemodialysis
10 patients will receive hemodialysis treatment (usual care)
Outcomes
Primary Outcome Measures
Change in blood pressure
Measured using standard clinical procedures (Automatic Blood Pressure Monitor at rest and with aneroid sphygmomanometer during and after exercise)
Change in perceived fatigue
10-centimeter horizontal visual analog scale, going from no fatigue (left) to extreme fatigue (right)
Change in perceived sleepiness
10-centimeter horizontal visual analog scale, going from no sleepiness (left) to extreme sleepiness (right)
Change in mood
10-centimeter horizontal visual analog scale, going from very bad (left) to very good (right)
Change in perceived soreness
10-centimeter horizontal visual analog scale, going from no soreness (left) to extreme soreness (right)
Change in perceived sleep quality
10-centimeter horizontal visual analog scale, going from very bad (left) to extreme soreness (right)
Plasma Metabolome and proteome at the end of the experimental (exercise) condition
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.
Plasma Metabolome and proteome at the end of the control (rest) condition
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.
Single pool Kt/V, experimental (exercise) condition
measured using standard clinical procedures (blood draw before and at the end of the dialysis session comprising the exercise condition, by a research nurse).
Single pool Kt/V, control (rest) condition
measured using standard clinical procedures (blood draw before and at the end of the dialysis session representing the condition, by a research nurse).
Secondary Outcome Measures
Hematocrit (%)
Routinely measured (monthly) as standard clinical practice, before a dialysis session.
Hemoglobin (g/L)
Routinely measured (monthly) as standard clinical practice, before a dialysis session.
Red blood cells count (10^12/L)
Routinely measured (monthly) as standard clinical practice, before a dialysis session.
White blood cells count (10^9/L)
Routinely measured (monthly) as standard clinical practice, before a dialysis session.
Platelets count (10^9/L)
Routinely measured (monthly) as standard clinical practice, before a dialysis session.
Red blood cell mean corpuscular hemoglobin (pg)
Routinely measured (monthly) as standard clinical practice, before a dialysis session.
Red blood cell mean corpuscular volume (fL)
Routinely measured (monthly) as standard clinical practice, before a dialysis session.
Red blood cell distribution width (%)
Routinely measured (monthly) as standard clinical practice, before a dialysis session.
Plasma sodium (mmol/L)
Routinely measured (monthly) as standard clinical practice, before a dialysis session.
Plasma potassium (mmol/L)
Routinely measured (monthly) as standard clinical practice, before a dialysis session.
Plasma calcium (mmol/L)
Routinely measured (monthly) as standard clinical practice, before a dialysis session.
Plasma phosphate (mmol/L)
Routinely measured (monthly) as standard clinical practice, before a dialysis session.
Plasma glucose (mmol/L)
Routinely measured (monthly) as standard clinical practice, before a dialysis session.
Plasma creatinine (mmol/L)
Routinely measured (monthly) as standard clinical practice, before a dialysis session.
Health-Related Quality of Life
French version of the Kidney Disease Quality of Life 36 items version 1.3 (KDQOL-36)
Disease-related symptoms
The French version of the Dialysis Symptom Index, consisting in a seven-day recall questionnaire assessing the presence and intensity of 30 symptoms
Physical activity scale for the Elderly (PASE) questionnaire
Recall questionnaire of the previous week's leisure, occupational and domestic physical activity habits validated in older adults.
Estimated daily energy expenditure
Wrist-worn accelerometer (Apple Watch)
Full Information
NCT ID
NCT05404698
First Posted
May 18, 2022
Last Updated
October 31, 2022
Sponsor
Université de Sherbrooke
Collaborators
Estrie University Integrated Health and Social Services Center - University Hospital of Sherbrooke
1. Study Identification
Unique Protocol Identification Number
NCT05404698
Brief Title
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
Acronym
CPExA
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
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
June 20, 2022 (Actual)
Primary Completion Date
July 15, 2022 (Actual)
Study Completion Date
September 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Université de Sherbrooke
Collaborators
Estrie University Integrated Health and Social Services Center - University Hospital of Sherbrooke
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multimorbidity - End-stage Kidney Disease
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Each participant performed 2 experimental conditions (rest, moderate continuous aerobic exercise with our cycle ergometer prototype - EXALT).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Aerobic intradialytic exercise
Arm Type
Experimental
Arm Description
10 patients will perform Aerobic exercise with the cycle ergometer prototype (EXALT) during hemodialysis
Arm Title
Standard care
Arm Type
Experimental
Arm Description
10 patients will receive hemodialysis treatment (usual care)
Intervention Type
Other
Intervention Name(s)
Aerobic exercise
Intervention Description
EX: 30 min of aerobic exercise (3/10 Borg scale) during hemodialysis treatment (between 30 min and 3h of treatment).
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
CONT: participants will receive hemodialysis treatment only (usual care)
Primary Outcome Measure Information:
Title
Change in blood pressure
Description
Measured using standard clinical procedures (Automatic Blood Pressure Monitor at rest and with aneroid sphygmomanometer during and after exercise)
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.
Title
Change in perceived fatigue
Description
10-centimeter horizontal visual analog scale, going from no fatigue (left) to extreme fatigue (right)
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).
Title
Change in perceived sleepiness
Description
10-centimeter horizontal visual analog scale, going from no sleepiness (left) to extreme sleepiness (right)
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).
Title
Change in mood
Description
10-centimeter horizontal visual analog scale, going from very bad (left) to very good (right)
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).
Title
Change in perceived soreness
Description
10-centimeter horizontal visual analog scale, going from no soreness (left) to extreme soreness (right)
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).
Title
Change in perceived sleep quality
Description
10-centimeter horizontal visual analog scale, going from very bad (left) to extreme soreness (right)
Time Frame
Measured at 10:00 am the day following the experimental condition.
Title
Plasma Metabolome and proteome at the end of the experimental (exercise) condition
Description
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.
Time Frame
After 30 minutes of exercise
Title
Plasma Metabolome and proteome at the end of the control (rest) condition
Description
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.
Time Frame
After 30 minutes of rest
Title
Single pool Kt/V, experimental (exercise) condition
Description
measured using standard clinical procedures (blood draw before and at the end of the dialysis session comprising the exercise condition, by a research nurse).
Time Frame
After 4 hours of dialysis
Title
Single pool Kt/V, control (rest) condition
Description
measured using standard clinical procedures (blood draw before and at the end of the dialysis session representing the condition, by a research nurse).
Time Frame
After 4 hours of dialysis
Secondary Outcome Measure Information:
Title
Hematocrit (%)
Description
Routinely measured (monthly) as standard clinical practice, before a dialysis session.
Time Frame
Extracted from each patient's medical record at inclusion.
Title
Hemoglobin (g/L)
Description
Routinely measured (monthly) as standard clinical practice, before a dialysis session.
Time Frame
Extracted from each patient's medical record at inclusion.
Title
Red blood cells count (10^12/L)
Description
Routinely measured (monthly) as standard clinical practice, before a dialysis session.
Time Frame
Extracted from each patient's medical record at inclusion.
Title
White blood cells count (10^9/L)
Description
Routinely measured (monthly) as standard clinical practice, before a dialysis session.
Time Frame
Extracted from each patient's medical record at inclusion.
Title
Platelets count (10^9/L)
Description
Routinely measured (monthly) as standard clinical practice, before a dialysis session.
Time Frame
Extracted from each patient's medical record at inclusion.
Title
Red blood cell mean corpuscular hemoglobin (pg)
Description
Routinely measured (monthly) as standard clinical practice, before a dialysis session.
Time Frame
Extracted from each patient's medical record at inclusion.
Title
Red blood cell mean corpuscular volume (fL)
Description
Routinely measured (monthly) as standard clinical practice, before a dialysis session.
Time Frame
Extracted from each patient's medical record at inclusion.
Title
Red blood cell distribution width (%)
Description
Routinely measured (monthly) as standard clinical practice, before a dialysis session.
Time Frame
Extracted from each patient's medical record at inclusion.
Title
Plasma sodium (mmol/L)
Description
Routinely measured (monthly) as standard clinical practice, before a dialysis session.
Time Frame
Extracted from each patient's medical record at inclusion.
Title
Plasma potassium (mmol/L)
Description
Routinely measured (monthly) as standard clinical practice, before a dialysis session.
Time Frame
Extracted from each patient's medical record at inclusion.
Title
Plasma calcium (mmol/L)
Description
Routinely measured (monthly) as standard clinical practice, before a dialysis session.
Time Frame
Extracted from each patient's medical record at inclusion.
Title
Plasma phosphate (mmol/L)
Description
Routinely measured (monthly) as standard clinical practice, before a dialysis session.
Time Frame
Extracted from each patient's medical record at inclusion.
Title
Plasma glucose (mmol/L)
Description
Routinely measured (monthly) as standard clinical practice, before a dialysis session.
Time Frame
Extracted from each patient's medical record at inclusion.
Title
Plasma creatinine (mmol/L)
Description
Routinely measured (monthly) as standard clinical practice, before a dialysis session.
Time Frame
Extracted from each patient's medical record at inclusion.
Title
Health-Related Quality of Life
Description
French version of the Kidney Disease Quality of Life 36 items version 1.3 (KDQOL-36)
Time Frame
Once, at the beginning of the dialysis session comprising the first condition
Title
Disease-related symptoms
Description
The French version of the Dialysis Symptom Index, consisting in a seven-day recall questionnaire assessing the presence and intensity of 30 symptoms
Time Frame
Twice, seven days after each experimental conditions
Title
Physical activity scale for the Elderly (PASE) questionnaire
Description
Recall questionnaire of the previous week's leisure, occupational and domestic physical activity habits validated in older adults.
Time Frame
Once, at the beginning of the dialysis session comprising the first condition
Title
Estimated daily energy expenditure
Description
Wrist-worn accelerometer (Apple Watch)
Time Frame
The watch will be worn during the 24 hours following each experimental condition
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Centre de recherche sur le vieillissement
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 4C4
Country
Canada
Facility Name
CIUSSS de l'Estrie - CHUS
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Waiting for the University policy - standard operating procedures and data (upon ethics approval) would be available upon reasonable request
Learn more about this trial
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
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