Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000375358
Ethics application status
Approved
Date submitted
15/07/2008
Date registered
31/07/2008
Date last updated
31/07/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of moderate-intensity strength training in people with heart failure
Scientific title
Randomized controlled trial assessing the effect of hospital-based moderate-intensity resistance exercise training versus no exercise training on skeletal muscle strength and endurance in patients with chronic systolic heart failure
Secondary ID [1] 647 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic systolic heart failure 3410 0
Condition category
Condition code
Cardiovascular 3562 3562 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
3 months (3 times per week, 1 hour per session) progressive resistance training exercise using a multistation hydraulic resistance training system (Hydra-Gym), leg cycling ergometers and a set of 5 stairs. The Hydra-Gym has 6 resistance settings for each movement. All participants started on setting 2 and progression to the next resistance setting was determined by the number of repetitions achieved within a given work interval in the two previous training sessions. When a patient remained symptom-free and recorded an increase of 25% in the number of repetitions achieved in a work interval during two consecutive training sessions, the resistance of that particular resistance activity was increased to the next setting.
Intervention code [1] 3137 0
Treatment: Other
Comparator / control treatment
No exercise training
Control group
Active

Outcomes
Primary outcome [1] 4463 0
Combined measure of unilateral skeletal muscle STRENGTH for knee and elbow extension/flexion (nM) using an isokinetic dynamometer (MERAC; Universal, Cedar Rapids, Iowa, USA) with microprocessor
Timepoint [1] 4463 0
Familiarisation (Week 0)
Baseline (Week 1)
Endpoint (after 3 months exercise training)
Primary outcome [2] 4464 0
Combined measure of unilateral skeletal muscle ENDURANCE for knee and elbow extension/flexion (joules) using an isokinetic dynamometer (MERAC; Universal, Cedar Rapids, Iowa, USA) with microprocessor
Timepoint [2] 4464 0
Familiarisation (Week 0)
Baseline (Week 1)
Endpoint (after 3 months exercise training)
Secondary outcome [1] 7533 0
Peak total body oxygen consumption (VO2peak) determined during a symptom-limited graded exercise test on an electronically-braked bicycle ergometer (Ergomed, Siemens, Erlangen, Germany)
Timepoint [1] 7533 0
Familiarisation (Week 0)
Baseline (Week 1)
Endpoint (after 3 months exercise training)
Secondary outcome [2] 7534 0
Forearm blood flow using venous occlusion plethysmography
Timepoint [2] 7534 0
Familiarisation (Week 0)
Baseline (Week 1)
Endpoint (after 3 months exercise training)
Secondary outcome [3] 7535 0
Heart rate variability using a Maclab system and Chart Extension software version 3.6.3 (ADI Instruments, Sydney, Australia)
Timepoint [3] 7535 0
Familiarisation (Week 0)
Baseline (Week 1)
Endpoint (after 3 months exercise training)
Secondary outcome [4] 7536 0
Angiotensin converting enzyme (ACE) genotype and its ability to predict responsiveness to resistance exercise training in these patients
Timepoint [4] 7536 0
Baseline

Eligibility
Key inclusion criteria
(i) Any aetiology of left ventricular systolic failure; (ii) left ventricular ejection fraction below 40%; (iii) stable pharmacological therapy with a minimum of two weeks unaltered drug therapy at entry.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(i) New York Heart Association (NYHA) Class IV patients with symptoms at rest or minimal activity; (ii) cardiovascular limitations that would prevent taking part in the exercise program such as previous cardiac arrest, symptomatic ventricular tachycardia or current exercise limitation because of angina; (iii) musculo-skeletal or respiratory problems that would prevent appropriate exercise; (iv) inadequate comprehension of English which would preclude understanding the study or completing quality of life questionnaires.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Computer generated random numbers held in sealed envelopes by a third party
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Groups balanced after every six patients using the block method described by Peto et al (1976)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/1997
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
45
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3596 0
Government body
Name [1] 3596 0
NHMRC
Country [1] 3596 0
Australia
Primary sponsor type
Individual
Name
Prof David L. Hare
Address
Department of Cardiology
Austin Hospital
Heidelberg VIC 3084
Country
Australia
Secondary sponsor category [1] 3232 0
Individual
Name [1] 3232 0
Prof Steve Selig
Address [1] 3232 0
School of Human Movement, Recreation & Performance
Victoria University
Melbourne VIC 8001
Country [1] 3232 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5710 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 5710 0
Ethics committee country [1] 5710 0
Australia
Date submitted for ethics approval [1] 5710 0
Approval date [1] 5710 0
03/11/1995
Ethics approval number [1] 5710 0
H95/099

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28751 0
Address 28751 0
Country 28751 0
Phone 28751 0
Fax 28751 0
Email 28751 0
Contact person for public queries
Name 11908 0
Deidre Toia
Address 11908 0
Department of Cardiology
Austin Hospital
Heidelberg VIC 3084
Country 11908 0
Australia
Phone 11908 0
+61 3 9496 3652
Fax 11908 0
Email 11908 0
[email protected]
Contact person for scientific queries
Name 2836 0
Prof David L. Hare
Address 2836 0
Department of Cardiology
Austin Hospital
Heidelberg VIC 3084
Country 2836 0
Australia
Phone 2836 0
+61 3 9496 3002
Fax 2836 0
Email 2836 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.