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

NCT05404698 | Completed

• 1 other identifier: 2023-4591
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

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.

Conditions

Multimorbidity - End-stage Kidney Disease

Outcome Measures

Primary Outcomes (10)

• Change in blood pressure

  Measured using standard clinical procedures (Automatic Blood Pressure Monitor at rest and with aneroid sphygmomanometer during and after exercise)

  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 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 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 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 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 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.

  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.

  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).

  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).

  After 4 hours of dialysis

Secondary Outcomes (18)

• Hematocrit (%)

  Extracted from each patient's medical record at inclusion.

• Hemoglobin (g/L)

  Extracted from each patient's medical record at inclusion.

• Red blood cells count (10^12/L)

  Extracted from each patient's medical record at inclusion.

• White blood cells count (10^9/L)

  Extracted from each patient's medical record at inclusion.

• Platelets count (10^9/L)

  Extracted from each patient's medical record at inclusion.

Study Arms (2)

Aerobic intradialytic exercise

EXPERIMENTAL

10 patients will perform Aerobic exercise with the cycle ergometer prototype (EXALT) during hemodialysis

Other: Aerobic exercise

Standard care

EXPERIMENTAL

10 patients will receive hemodialysis treatment (usual care)

Other: Control

Interventions

Aerobic exercise OTHER

EX: 30 min of aerobic exercise (3/10 Borg scale) during hemodialysis treatment (between 30 min and 3h of treatment).

Aerobic intradialytic exercise

Control OTHER

CONT: participants will receive hemodialysis treatment only (usual care)

Standard care

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Université de Sherbrooke: lead
• Estrie University Integrated Health and Social Services Center - University Hospital of Sherbrooke: collaborator

Study Sites (2)

Centre de recherche sur le vieillissement

Sherbrooke, Quebec, J1H 4C4, Canada

Location

CIUSSS de l'Estrie - CHUS

Sherbrooke, Quebec, J1H 5N4, Canada

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each participant performed 2 experimental conditions (rest, moderate continuous aerobic exercise with our cycle ergometer prototype - EXALT).

Study Record Dates

• First Submitted: May 18, 2022
• First Posted: June 3, 2022
• Study Start: June 20, 2022
• Primary Completion: July 15, 2022
• Study Completion: September 15, 2022
• Last Updated: November 3, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)