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Trial of Hemodialysis Based Exercise for Strength Improvement Study (THESIS Trial)

N/A
Waitlist Available
Research Sponsored by St. Joseph's Healthcare Hamilton
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 and 20 weeks
Awards & highlights
No Placebo-Only Group

Summary

Study Hypothesis: The combination of aerobic and resistance exercise training will improve walking speed compared to either individual intervention. Brief Summary: Sixty hemodialysis participants who meet inclusion and exclusion criteria will be randomized to 20 weeks of supervised exercise, using either: (i) on-dialysis aerobic exercise using a bike ergometer; (ii) pre-dialysis leg strength training using weights; or (iii) both. The primary outcome is walking speed over 4-metres. Secondary outcomes will include: (i) short physical performance battery; (ii) health-related quality of life \[EuroQOL-5D-5L\]; (iii) Dialysis recovery time; (iv) Nottingham extended activities of daily living (EADL) index; (v) Leg strength; (vi) body composition and anthropometry.

Eligible Conditions
  • Kidney Failure

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 and 20 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 and 20 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
change in walking speed over 20 weeks
Secondary study objectives
change in EuroQOL-5D-5L over 20 weeks
change in Nottingham extended activities of daily living index over 20 weeks
change in body anthropometry and composition over 20 weeks.
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: aerobic exercise and resistance trainingExperimental Treatment2 Interventions
patients will undergo a combination of aerobic exercise and resistance training on an alternating schedule three time per week
Group II: aerobic exerciseActive Control1 Intervention
patients will undergo supervised exercise on a bike ergometer for 30 minutes three times per week during hemodialysis
Group III: resistance trainingActive Control1 Intervention
patients will undergo supervised lower extremity strength training three times per week pre-hemodialysis

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Who is running the clinical trial?

St. Joseph's Healthcare HamiltonLead Sponsor
202 Previous Clinical Trials
26,865 Total Patients Enrolled
~5 spots leftby Jan 2026