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Optimising clinical and functional outcomes in older adults with Heart Failure (HF) using the Peripheral Remodeling through Intermittent Muscular Exercise (PRIME) approach: A pilot study

Optimising clinical and functional outcomes in older adults with Heart Failure (HF) using the Peripheral Remodeling through Intermittent Muscular Exercise (PRIME) approach: A pilot study

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619000253101
Acronym
PRIME-HF
Enrollment
23
Registered
2019-02-20
Start date
2016-06-30
Completion date
2018-05-22
Last updated
2019-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Guidelines recommended moderate intensity aerobic exercise for all patients with HF, however many exercise training studies include a patient group much younger than the 'real world' patient with HF who is elderly. This study was designed with a dual focus to address the age gap seen in HF exercise trials, while simultaneous gathering preliminary data for a novel rehabilitation technique called Peripheral Remodelling through Intermittent Muscular Exercise: “PRIME”. The PRIME approach offers a ‘hybrid’ aerobic-resistance solution for individuals with HF who may be unable to participate in conventional exercise training. This study will assess the feasibility of conducting a future large trial, to determine if 4 weeks of PRIME training, followed by 4 weeks of traditional HF rehabilitation (combination aerobic plus resistance exercise) can produce superior gains in aerobic capacity and muscle strength in comparison to 8 weeks of traditional HF rehabilitation, in elderly patients with HF.

Interventions

This pilot study will employ a randomised controlled, single-blinded parallel group design to test the hypothesis that 4 weeks of PRIME training, prior to 4 weeks of traditional HF rehabilitation (combination aerobic plus resistance exercise) is a feasible ‘primer’ to produce relevant additive gains in primary efficacy outcomes of aerobic capacity and muscle strength in comparison to 8 weeks of traditional HF rehabilitation, in elderly patients with HF. Participants were randomised in a 1:1 rat

This pilot study will employ a randomised controlled, single-blinded parallel group design to test the hypothesis that 4 weeks of PRIME training, prior to 4 weeks of traditional HF rehabilitation (combination aerobic plus resistance exercise) is a feasible ‘primer’ to produce relevant additive gains in primary efficacy outcomes of aerobic capacity and muscle strength in comparison to 8 weeks of traditional HF rehabilitation, in elderly patients with HF. Participants were randomised in a 1:1 ratio to PRIME or COMBO training for the first 4 weeks, after which all participants will complete a further 4 weeks of COMBO training. All exercise-training sessions lasted 60 minutes, including warm-up, training, and cooldown and were conducted twice per week for a total of 8 weeks. Participants were supervised by an accredited exercise physiologist’s and an attendance record kept and documented daily. Exercise sessions were conducted at the Victoria University Clinical Exercise Rehabilitation Clinic and/or the Western Centre for Health, Research and Education. In the case of missed exercise sessions, catch up sessions were offered. The PRIME protocol included eight exercises completed within 60 min including warm-up, rest periods, stretching between exercises, and cooldown activities (see Table 1 in attached research protocol). Each exercise started at approximately 50% of 1RM at a cadence of 1 concentric phase every 4 seconds for a period of 5 minutes. During each exercise subjects were allowed to take breaks as needed with each for a minimum of 30 seconds. Progression was made first by decreasing the number of required rest periods during each exercise. When the subject could complete the whole duration of the exercise (6 minutes) without rest the load was increased by ~10%.

Sponsors

Western Health Research Grant 2016 (Sunshine Hospital)
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

i) a diagnosis of HF with reduced ejection fraction (HFrEF) as defined by ESC Guidelines 2016 (left ventricular ejection fraction <40%) and confirmed by the study cardiologist (ii) age greater than or equal to 65 years and (iii) mild to moderate symptomatology (NYHA II-III).

Exclusion criteria

Exclusion from the study resulted from the presence of absolute contraindications to exercise training, as per reported criteria for participation in exercise for people with HF, including: • Progressive worsening of exercise tolerance, dyspnoea or other symptoms suggestive of deterioration of heart failure or acute illness • Severe aortic stenosis or severe valvular disease • Unstable Angina • Resting systolic pressure greater than or equal to 160 mmHg or diastolic BP greater than or equal to 95 mmHg • Resting heart rate greater than or equal to 100 bpm • Complex ventricular arrhythmia at rest or appearing with exertion • Neuromuscular, musculoskeletal, or rheumatoid disorders that are exacerbated by exercise

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026