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

NCT ID: NCT05404698

Last Updated: 2022-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-20

Study Completion Date

2022-09-15

Brief Summary

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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.

Detailed Description

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Conditions

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Multimorbidity - End-stage Kidney Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Each participant performed 2 experimental conditions (rest, moderate continuous aerobic exercise with our cycle ergometer prototype - EXALT).
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Aerobic intradialytic exercise

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

Group Type EXPERIMENTAL

Aerobic exercise

Intervention Type OTHER

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

Standard care

10 patients will receive hemodialysis treatment (usual care)

Group Type EXPERIMENTAL

Control

Intervention Type OTHER

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

Interventions

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Aerobic exercise

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

Intervention Type OTHER

Control

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

60 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Estrie University Integrated Health and Social Services Center - University Hospital of Sherbrooke

OTHER

Sponsor Role collaborator

Université de Sherbrooke

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centre de recherche sur le vieillissement

Sherbrooke, Quebec, Canada

Site Status

CIUSSS de l'Estrie - CHUS

Sherbrooke, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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2023-4591

Identifier Type: -

Identifier Source: org_study_id

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