Acceptability of High Intensity Functional Training in people with Parkinson's: a randomised feasibility trial protocol
Abstract
Background & Rationale
Parkinson’s disease prevalence is rising globally, driven by an ageing population. High intensity exercise may slow symptom progression and improve physical function, bone health, and quality of life. One way of delivering this is through High intensity functional training (HIFT) via community providers such as CrossFit and PD Warrior relieving pressure on NHS resources.
Objectives
To assess the acceptability, safety and feasibility of delivering HIFT to people with Parkinson’s through external providers, providing foundational information for future definitive trial design.
Methods
This randomised controlled feasibility trial will recruit 57 participants identified through GP surgeries across the Bristol, North Somerset and South Gloucestershire Integrated Care Board over nine-months and randomised (2:1) to intervention or control arm.
Eligibility criteria include diagnosis of idiopathic Parkinson’s, independent mobility, and stable medication. Exclusion criteria include severe motor-fluctuations, cognitive impairment and orthostatic hypotension.
The intervention comprises either CrossFit or PD Warrior classes delivered in-person or at home, aiming for ≥2 sessions per week for 12 weeks. CrossFit participants will be supervised by a trial physiotherapist for safety. Intervention and control groups will complete exercise diaries. Baseline and follow-up (12-weeks) assessments will be in-person comprising physical assessments and questionnaires. Questionnaires will be completed at 6-weeks.
Primary outcomes include recruitment, retention, adherence and safety. Secondary outcomes include physical function, cognition, symptom severity, balance and quality of life. Study data will be collected via questionnaires, physical assessments and exercise diaries, and held securely in a study database (REDCap).
A concurrent qualitative study (15-20 participants guided by information power) will explore experiences of the trial through semi-structured interviews analysed using Thematic Analysis.
Ethical approval has been obtained from NHS-REC/HRA (ref:26/WS/0029), with a trial steering committee and patient advisory group providing independent oversight. Dissemination will occur through peer-reviewed publications, presentation at academic conferences, and a published lay summary.