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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)

U

Université de Sherbrooke

Status

Completed

Conditions

Multimorbidity - End-stage Kidney Disease

Treatments

Other: Aerobic exercise
Other: Control

Study type

Interventional

Funder types

Other

Identifiers

NCT05404698
2023-4591

Details and patient eligibility

About

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.

Enrollment

10 patients

Sex

All

Ages

60 to 85 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

10 participants in 2 patient groups

Aerobic intradialytic exercise
Experimental group
Description:
10 patients will perform Aerobic exercise with the cycle ergometer prototype (EXALT) during hemodialysis
Treatment:
Other: Aerobic exercise
Standard care
Experimental group
Description:
10 patients will receive hemodialysis treatment (usual care)
Treatment:
Other: Control

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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