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

St. Joseph's Healthcare Hamilton

Status: Unknown

Conditions: End Stage Renal Disease

Treatments: Other: aerobic exercise; Other: resistance training

Study type: Interventional

Funder types: Other

Identifiers

NCT01962597

13-468

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• At least 18 years of age
• On hemodialysis minimum of 3 times per week
• On hemodialysis > 3 consecutive months

Exclusion criteria

• Inability to provide consent
• Inability to walk 4-metres
• Chest pain with exertion or myocardial infarction in past 6-months
• Pre-dialysis systolic blood pressure > 200 mm Hg or diastolic BP > 100 mm Hg in past 2-weeks
• Functional or cardiorespiratory limitations preventing use of cycle ergometer for at least five-minutes or the ability to perform single maximum rep with each of resistance exercises described
• Joint replacement or lower extremity fracture in previous 6-months
• Severe cognitive impairment
• Currently using corticosteroids >5 mg/day
• Pre-dialysis serum potassium in previous month less than 3.5 or greater than 6.0 mmol/L.
• Attending nephrologist feels exercise is medically contraindicated
• Scheduled living related kidney transplant in next 6 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 3 patient groups

aerobic exercise

Active Comparator group

Description:

patients will undergo supervised exercise on a bike ergometer for 30 minutes three times per week during hemodialysis

Treatment:

Other: aerobic exercise

resistance training

Active Comparator group

Description:

patients will undergo supervised lower extremity strength training three times per week pre-hemodialysis

Treatment:

Other: resistance training

aerobic exercise and resistance training

Experimental group

Description:

patients will undergo a combination of aerobic exercise and resistance training on an alternating schedule three time per week

Treatment:

Other: resistance training

Other: aerobic exercise