ANZCTR - Registration

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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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Chronic systolic heart failure

Condition category

Condition code

Cardiovascular

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]

Treatment: Other

Comparator / control treatment

No exercise training

Control group

Active

Outcomes

Primary outcome [1]

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]

Familiarisation (Week 0)
Baseline (Week 1)
Endpoint (after 3 months exercise training)

Primary outcome [2]

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]

Familiarisation (Week 0)
Baseline (Week 1)
Endpoint (after 3 months exercise training)

Secondary outcome [1]

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]

Familiarisation (Week 0)
Baseline (Week 1)
Endpoint (after 3 months exercise training)

Secondary outcome [2]

Forearm blood flow using venous occlusion plethysmography

Timepoint [2]

Familiarisation (Week 0)
Baseline (Week 1)
Endpoint (after 3 months exercise training)

Secondary outcome [3]

Heart rate variability using a Maclab system and Chart Extension software version 3.6.3 (ADI Instruments, Sydney, Australia)

Timepoint [3]

Familiarisation (Week 0)
Baseline (Week 1)
Endpoint (after 3 months exercise training)

Secondary outcome [4]

Angiotensin converting enzyme (ACE) genotype and its ability to predict responsiveness to resistance exercise training in these patients

Timepoint [4]

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]

Government body

Name [1]

NHMRC

Address [1]

Level 5, 20 Allara Street
Canberra ACT 2601

Country [1]

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]

Individual

Name [1]

Prof Steve Selig

Address [1]

School of Human Movement, Recreation & Performance
Victoria University
Melbourne VIC 8001

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Austin Health Human Research Ethics Committee

Ethics committee address [1]

Level 8 HSB
Austin Hospital
Studley Rd
Heidelber VIC 3084

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

03/11/1995

Ethics approval number [1]

H95/099

Summary

Brief summary

The purpose of this study is to identify whether resistance (weight) training results in improvements in fitness and well being for patients with stable chronic systolic heart failure. Systolic heart failure is a condition where the heart muscle cannot pump blood as vigorously as usual. Resistance exercise training involves the use of muscle groups to push and pull against a smooth hydraulic force. In this study participants are randomly allocated to 3 months of either resistance exercise training or no exercise training. Tests are carried out before, during and after the 3-month period to determine differences between the 2 groups in a number of measures of fitness and well being.

Trial website

Trial related presentations / publications

1.Hare DL, Ryan TM, Selig SE, Pellizzer A-M, Wrigley TV, Krum H. Resistance exercise training increases muscle strength, endurance and blood flow in patients with chronic heart failure. American Journal of Cardiology 1999; 83: 1674-1677
2.Selig SE, Menzies DG, Gosling CMcR, Krum H, Carey MF, Williams A, Toia D, Bamroongsuk V, Hare DL. Effects of resistance exercise training on muscle strength and exercise capacity in chronic heart failure: a prospective randomised study. Circulation 2000; 102(suppl II): 656 (abst)
3.Williams AD, Selig S, Hare DL, Krum H, Hayes A, Menzies D, Patterson J, Geerling R, Butler N, Bamroongsuk V, Toia D, Carey MF. Exercise limitation in chronic heart failure is caused by structural changes in skeletal muscle not reduced oxidative capacity. Circulation 2001; 104 (suppl II): 453
4.Hare DL, Anderson MJ, Febbraio MA, Harrup SB, Williams A, Carey MF, Selig S. ACE gene polymorphism is not a predictor of chronic heart failure or aerobic fitness. Circulation 2001; 104 (suppl II): 553
5.Selig SE, Carey MF, Menzies DG, Paterson J, Geerling R, Williams AD, Bamroongsuk V, Toia D, Krum H, Hare DL.  Reliability of isokinetic testing and aerobic power testing in patients with chronic heart failure. Journal of Cardiopulmonary Rehabilitation 2002; 22:282-289
6.Williams AD, Selig S, Hare DL, Hayes A, Krum H, Patterson J, Geerling RH, Toia D, and Carey MF. Reduced exercise tolerance in CHF may be related to factors other than impaired skeletal muscle oxidative capacity. Journal of Cardiac Failure 2004; 10(2): 141-148
7.Selig SE, Carey MF, Menzies DG, Patterson J, Geerling RH, Williams AD, Bamroongsuk V, Toia D, Krum H & Hare DL Moderate-intensity resistance exercise training in patients with chronic heart failure improves strength, endurance, heart rate variability and forearm blood flow. Journal of Cardiac Failure 2004; 10(1):21-30
8.Williams AD, Carey MF, Selig S, Hayes A, Krum H, Patterson J, Toia D, and Hare DL. Circuit resistance training in chronic heart failure improves skeletal muscle mitochondrial ATP production rate - a randomised controlled trial. Journal of Cardiac Failure 2007; 13(2): 79-85
9.Patterson JA, Selig SE, Toia D, Bamroongsuk V, Hare DL. Forearm blood flow in individuals with CHF and age-matched healthy volunteers: a study and historical review. Journal of Exercise Physiology 2007; 10 (5) JEP Online (October 2007)

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Email

Contact person for public queries

Name

Deidre Toia

Address

Department of Cardiology
Austin Hospital
Heidelberg VIC 3084

Country

Australia

Phone

+61 3 9496 3652

Fax

Email

deidre.toia@austin.org.au

Contact person for scientific queries

Name

Prof David L. Hare

Address

Department of Cardiology
Austin Hospital
Heidelberg VIC 3084

Country

Australia

Phone

+61 3 9496 3002

Fax

Email

david.hare@austin.org.au

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.