NCT01962597

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

October 8, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 14, 2013

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

April 19, 2016

Status Verified

April 1, 2016

Enrollment Period

3.7 years

First QC Date

October 8, 2013

Last Update Submit

April 18, 2016

Conditions

End Stage Renal Disease

Keywords

hemodialysisaerobic exerciseresistance trainingwalking speedrandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • change in walking speed over 20 weeks

    repeated measures analysis

    10 and 20 weeks

Secondary Outcomes (8)

  • change in short physical performance battery over 20 weeks

    10 and 20 weeks

  • change in EuroQOL-5D-5L over 20 weeks

    10 and 20 weeks

  • change in dialysis recovery time over 20 weeks

    10 and 20 weeks

  • change in Nottingham extended activities of daily living index over 20 weeks

    10 and 20 weeks

  • change in body anthropometry and composition over 20 weeks.

    10 and 20 weeks

  • +3 more secondary outcomes

Study Arms (3)

aerobic exercise

ACTIVE COMPARATOR

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

Other: aerobic exercise

resistance training

ACTIVE COMPARATOR

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

Other: resistance training

aerobic exercise and resistance training

EXPERIMENTAL

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

Other: aerobic exerciseOther: resistance training

Interventions

aerobic exerciseOTHER
aerobic exerciseaerobic exercise and resistance training
resistance trainingOTHER
aerobic exercise and resistance trainingresistance training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Josephs Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

ExerciseResistance Training

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, Human

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Nephrologist/Associate Professor of Medicine

Study Record Dates

First Submitted

October 8, 2013

First Posted

October 14, 2013

Study Start

October 1, 2013

Primary Completion

June 1, 2017

Study Completion

September 1, 2017

Last Updated

April 19, 2016

Record last verified: 2016-04

Locations

CA(1)