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Trial registered on ANZCTR

Registration number

ACTRN12623000055606

Ethics application status

Approved

Date submitted

7/01/2023

Date registered

17/01/2023

Date last updated

17/01/2023

Date data sharing statement initially provided

17/01/2023

Type of registration

Retrospectively registered

Titles & IDs

Public title

Does the addition of high-intensity single muscle group training improve exercise training efficiency in heart failure?

Scientific title

Does the addition of high-intensity small muscle mass training result in greater improvements in exercise capacity, physical performance, muscle strength and health-related quality of life outcomes for individuals with heart failure?

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

heart failure

Condition category

Condition code

Cardiovascular

Other cardiovascular diseases

Physical Medicine / Rehabilitation

Other physical medicine / rehabilitation

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

High-intensity small muscle mass training (HISMT) plus modified standard training (MST): Participants will undertake isolated knee extensor HISMT during twice weekly exercise sessions, with the training load increased as tolerated over the 12-week training period. The HISMT protocol will consist of a series of bilateral, dynamic knee extension exercises against a resistive load using a knee extensor machine. This training will be undertaken as 3 sets of up 25 repetitions, with a concentric-eccentric contraction time ratio of 1:2. During each session, participants will also undertake a modified version of the standard training (ST; described in comparator/control treatment section below) so that the total volume of work is similar to those undertaking ST alone. The perceived levels of exertion (using the Borg 0-10 category ratio (CR) scale), quadriceps muscle fatigue (using the Borg 0-10 CR scale) and knee pain (using a 0-10 integer numerical rating scale; 0 – no pain, 10 – worst pain imaginable) will be ascertained prior to commencing the HISMT protocol and following completion of each set. The aim of the HISMT protocol is to achieve temporary muscle failure at the end of each set (determined by quadriceps muscle fatigue rating of at least 7 on the Borg 0-10 CR scale), without eliciting any adverse signs or symptoms or musculoskeletal pain. The exercise training will be administered by a physiotherapy clinician with a minimum of 10 years experience and undertaken within a face-to-face, group-based outpatient HF rehabilitation program at two sites i.e. Gold Coast Hospital and Health Service (GCHHS) and The Prince Charles Hospital (TPCH). Each training session has capacity for up to 12 patients and is approximately 90 minutes in duration. Adherence to the allocated intervention will be monitored by means of session attendance and completion of the prescribed exercise program.

Intervention code [1]

Rehabilitation

Comparator / control treatment

Standard training (ST) alone: Participants will be given the standard centre-based, outpatient rehabilitation program provided by the GCHHS and TPCH HF exercise programs (HFEPs), in which patients attend twice weekly face-to-face, group-based exercise sessions for 12 weeks. The training sessions have capacity for up to 12 patients. During the sessions, patients undertake a combination of upper and lower extremity aerobic- and resistance-based exercises e.g. treadmill walking, stationary bicycle, arm ergometer, sit-to-stand, mini squats, calf raises, bicep curls and wall push-ups. The initial target training intensity range is 11 to 13 as assessed by the Borg 6-20 Rating of Perceived Exertion (RPE) scale, with patients aiming to achieve 12 to 14 at subsequent sessions as tolerated. Observations (heart rate, oxygen saturation and blood pressure, as well as blood glucose levels if required) are taken at the start and on completion of the exercise session. A medical screen is conducted to ensure clinical stability and safety for exercise. Each exercise session is approximately 90 minutes in duration, beginning with a 10-15 minute warm-up of low-intensity aerobic exercise and concluding with a 15 minute cool-down consisting of a low-intensity aerobic exercise and static upper and lower body stretches. The exercise training program is administered by a physiotherapy clinician with a minimum of 10 years experience and supported by nursing staff. After each session, the exercise prescription is reviewed by a physiotherapist and progressed based on the person’s tolerance of their set program and clinical parameters. Adherence to the allocated intervention will be monitored by means of session attendance and completion of the prescribed exercise program.

Control group

Active

Outcomes

Primary outcome [1]

Exercise capacity as assessed by the six-minute walk test (6MWT)

Timepoint [1]