Multimorbidity - End-stage Kidney DiseaseCPExANCT05404698
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
A study testing Aerobic exercise in people with Multimorbidity - End-stage Kidney Disease, run by Université de Sherbrooke at 2 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Multimorbidity - End-stage Kidney Disease
- What is being tested?
- Aerobic exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesCanada
- Study dates
- 20 Jun 2022to 15 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- being treated by hemodialysis for end-stage kidney disease for at least 3 months
- medically eligible
Who cannot join
- diagnosed neurocognitive decline
- hip fracture with recent hemiarthroplasty preventing hip flexion while pedalling,
- COVID-19 positive,
- already included in another study.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Centre de recherche sur le vieillissement
Sherbrooke, Quebec, J1H 4C4
CIUSSS de l'Estrie - CHUS
Sherbrooke, Quebec, J1H 5N4
About this study
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
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.
- Being tested
- Aerobic exercise, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exerciseOther
EX: 30 min of aerobic exercise (3/10 Borg scale) during hemodialysis treatment (between 30 min and 3h of treatment).
ControlOther
CONT: participants will receive hemodialysis treatment only (usual care)
| Study group | Role | What they receive |
|---|---|---|
| Aerobic intradialytic exercise | Experimental | 10 patients will perform Aerobic exercise with the cycle ergometer prototype (EXALT) during hemodialysis Receives: Other: Aerobic exercise |
| Standard care | Experimental | 10 patients will receive hemodialysis treatment (usual care) Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood pressure
Measured using standard clinical procedures (Automatic Blood Pressure Monitor at rest and with aneroid sphygmomanometer during and after exercise)
Measured: 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.
Change in perceived fatigue
10-centimeter horizontal visual analog scale, going from no fatigue (left) to extreme fatigue (right)
Measured: 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).
Change in perceived sleepiness
10-centimeter horizontal visual analog scale, going from no sleepiness (left) to extreme sleepiness (right)
Measured: 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).
Change in mood
10-centimeter horizontal visual analog scale, going from very bad (left) to very good (right)
Measured: 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).
Change in perceived soreness
10-centimeter horizontal visual analog scale, going from no soreness (left) to extreme soreness (right)
Measured: 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).
Change in perceived sleep quality
10-centimeter horizontal visual analog scale, going from very bad (left) to extreme soreness (right)
Measured: Measured at 10:00 am the day following the experimental condition.
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.
Measured: After 30 minutes of exercise
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.
Measured: After 30 minutes of rest
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).
Measured: After 4 hours of dialysis
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).
Measured: After 4 hours of dialysis
Secondary outcomes (18)
Hematocrit (%)
Routinely measured (monthly) as standard clinical practice, before a dialysis session.
Measured: Extracted from each patient's medical record at inclusion.
Hemoglobin (g/L)
Routinely measured (monthly) as standard clinical practice, before a dialysis session.
Measured: Extracted from each patient's medical record at inclusion.
Red blood cells count (10^12/L)
Routinely measured (monthly) as standard clinical practice, before a dialysis session.
Measured: Extracted from each patient's medical record at inclusion.
White blood cells count (10^9/L)
Routinely measured (monthly) as standard clinical practice, before a dialysis session.
Measured: Extracted from each patient's medical record at inclusion.
Platelets count (10^9/L)
Routinely measured (monthly) as standard clinical practice, before a dialysis session.
Measured: Extracted from each patient's medical record at inclusion.
Red blood cell mean corpuscular hemoglobin (pg)
Routinely measured (monthly) as standard clinical practice, before a dialysis session.
Measured: Extracted from each patient's medical record at inclusion.
Red blood cell mean corpuscular volume (fL)
Routinely measured (monthly) as standard clinical practice, before a dialysis session.
Measured: Extracted from each patient's medical record at inclusion.
Red blood cell distribution width (%)
Routinely measured (monthly) as standard clinical practice, before a dialysis session.
Measured: Extracted from each patient's medical record at inclusion.
Plasma sodium (mmol/L)
Routinely measured (monthly) as standard clinical practice, before a dialysis session.
Measured: Extracted from each patient's medical record at inclusion.
Plasma potassium (mmol/L)
Routinely measured (monthly) as standard clinical practice, before a dialysis session.
Measured: Extracted from each patient's medical record at inclusion.
Plasma calcium (mmol/L)
Routinely measured (monthly) as standard clinical practice, before a dialysis session.
Measured: Extracted from each patient's medical record at inclusion.
Plasma phosphate (mmol/L)
Routinely measured (monthly) as standard clinical practice, before a dialysis session.
Measured: Extracted from each patient's medical record at inclusion.
Plasma glucose (mmol/L)
Routinely measured (monthly) as standard clinical practice, before a dialysis session.
Measured: Extracted from each patient's medical record at inclusion.
Plasma creatinine (mmol/L)
Routinely measured (monthly) as standard clinical practice, before a dialysis session.
Measured: Extracted from each patient's medical record at inclusion.
Health-Related Quality of Life
French version of the Kidney Disease Quality of Life 36 items version 1.3 (KDQOL-36)
Measured: Once, at the beginning of the dialysis session comprising the first condition
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
Measured: Twice, seven days after each experimental conditions
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.
Measured: Once, at the beginning of the dialysis session comprising the first condition
Estimated daily energy expenditure
Wrist-worn accelerometer (Apple Watch)
Measured: The watch will be worn during the 24 hours following each experimental condition
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2022
- Study start20 Jun 2022
- Primary completion15 Jul 2022
- Study completion15 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multimorbidity - End-stage Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Each participant performed 2 experimental conditions (rest, moderate continuous aerobic exercise with our cycle ergometer prototype - EXALT).
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Collaborators
- Estrie University Integrated Health and Social Services Center - University Hospital of Sherbrooke
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05404698
- Sponsor's protocol ID
- 2023-4591
- Acronym
- CPExA
- Status last verified
- Oct 2022
- First submitted
- 18 May 2022
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Waiting for the University policy - standard operating procedures and data (upon ethics approval) would be available upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05404698
- Acronym / sponsor ID
- CPExA / 2023-4591
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Collaborators
- Estrie University Integrated Health and Social Services Center - University Hospital of Sherbrooke
- Study start
- 20 Jun 2022 (actual)
- Primary completion
- 15 Jul 2022 (actual)
- Study completion
- 15 Sep 2022 (actual)
- First posted
- 3 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Each participant performed 2 experimental conditions (rest, moderate continuous aerobic exercise with our cycle ergometer prototype - EXALT).
| Arm | Type | Receives |
|---|---|---|
| Aerobic intradialytic exercise | Experimental | Other: Aerobic exercise10 patients will perform Aerobic exercise with the cycle ergometer prototype (EXALT) during hemodialysis |
| Standard care | Experimental | Other: Control10 patients will receive hemodialysis treatment (usual care) |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- being treated by hemodialysis for end-stage kidney disease for at least 3 months
- medically eligible
Key exclusion criteria (4 listed)
- diagnosed neurocognitive decline
- hip fracture with recent hemiarthroplasty preventing hip flexion while pedalling,
- COVID-19 positive,
- already included in another study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic exerciseEX: 30 min of aerobic exercise (3/10 Borg scale) during hemodialysis treatment (between 30 min and 3h of treatment). | Other | Aerobic intradialytic exercise |
| ControlCONT: participants will receive hemodialysis treatment only (usual care) | Other | Standard care |
Primary outcome
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)
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)
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)
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)
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)
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)
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.
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.
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).
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).
18 secondary outcomes
Hematocrit (%)
Time frame: Extracted from each patient's medical record at inclusion.
Hemoglobin (g/L)
Time frame: Extracted from each patient's medical record at inclusion.
Red blood cells count (10^12/L)
Time frame: Extracted from each patient's medical record at inclusion.
White blood cells count (10^9/L)
Time frame: Extracted from each patient's medical record at inclusion.
Platelets count (10^9/L)
Time frame: Extracted from each patient's medical record at inclusion.
Red blood cell mean corpuscular hemoglobin (pg)
Time frame: Extracted from each patient's medical record at inclusion.
Red blood cell mean corpuscular volume (fL)
Time frame: Extracted from each patient's medical record at inclusion.
Red blood cell distribution width (%)
Time frame: Extracted from each patient's medical record at inclusion.
Plasma sodium (mmol/L)
Time frame: Extracted from each patient's medical record at inclusion.
Plasma potassium (mmol/L)
Time frame: Extracted from each patient's medical record at inclusion.
Plasma calcium (mmol/L)
Time frame: Extracted from each patient's medical record at inclusion.
Plasma phosphate (mmol/L)
Time frame: Extracted from each patient's medical record at inclusion.
Plasma glucose (mmol/L)
Time frame: Extracted from each patient's medical record at inclusion.
Plasma creatinine (mmol/L)
Time frame: Extracted from each patient's medical record at inclusion.
Health-Related Quality of Life
Time frame: Once, at the beginning of the dialysis session comprising the first condition
Disease-related symptoms
Time frame: Twice, seven days after each experimental conditions
Physical activity scale for the Elderly (PASE) questionnaire
Time frame: Once, at the beginning of the dialysis session comprising the first condition
Estimated daily energy expenditure
Time frame: The watch will be worn during the 24 hours following each experimental condition
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
- Individual participant dataSharing planned: No. Waiting for the University policy - standard operating procedures and data (upon ethics approval) would be available upon reasonable request
Related trials for Multimorbidity - End-stage Kidney Disease
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Older Kidney Patient Optimisation Pretransplant
Kidney Disease, Kidney Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercise in people with Multimorbidity - End-stage Kidney Disease, run by Université de Sherbrooke at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2022.