Table 1 World Health Organization Trial Registration Data Set
Data category | Information |
|---|---|
Primary registry and trial identifying number | ISRCTN10608766 |
Date of registration in primary registry | 18th March 2019 |
Secondary identifying numbers | REC reference: 19/WM/0155 NIHR HTA reference: 17/129/02 |
Source(s) of monetary or material support | NIHR Health Technology Assessment grant |
Primary sponsor | UHCW NHS Trust University Hospital Clifford Bridge Rd., Coventry CV2 2DX Tel: 02476 966,195 Email: R&DSponsorship@uhcw.nhs.uk |
Secondary sponsor(s) | n/a |
Contact for public queries | SPHERe Resource Warwick Clinical Trials Unit Tel: 02476150285 Email: sphere@warwick.ac.uk |
Contact for scientific queries | Dr Gordon McGregor Warwick Clinical Trials Unit Tel: 02476150285 |
Public title | Supervise exercise rehabilitation for people with pulmonary hypertension |
Scientific title | Supervised Pulmonary Hypertension Exercise REhabilitation (SPHERe): a multi-centre randomised controlled trial |
Countries of recruitment | England |
Health condition(s) or problem(s) studied | Pulmonary hypertension (PH) (groups 1–5) |
Intervention(s) | Intervention group: 1) Individual assessment and exercise familiarisation, 2) Supervised out-patient exercise programme, 3) Psychosocial and motivational support; and education, 4) Guided home exercise plan. Control intervention: Best practice usual care |
Key inclusion and exclusion criteria | Inclusion: Adults (18+) with confirmed PH (groups 1 to 5), clinically stable, WHO functional class II, III or IV, fluent in spoken English, travelling distance of a SPHERe centre, ability to provide informed consent. Exclusion: Absolute contra-indications to exercise, PH-related complications, or comorbidities severe enough to prevent attendance at a SPHERe centre, or exercise, mental health issue preventing engagement with trial procedures, previous randomisation in SPHERe, pregnant at time of recruitment |
Study type | Type: Pragmatic, interventional, multi-centre Allocation: randomised Assignment: parallel Masking: outcomes assessors, chief investigator, statistician |
Date of first enrolment | 15th January 2020 |
Target sample size | 382 |
Recruitment status | Recruiting |
Primary outcome(s) | Incremental shuttle walk test at four months |
Key secondary outcomes | At 4 and 12 months: Six-minute walk test, Cambridge Pulmonary Hypertension Outcome Review, Hospital Anxiety and Depression Scale, Generalised self-efficacy scale, Fatigue Severity Scale, WHO functional class, Medication use, Time to clinical worsening, Hospital admissions, Adverse events, All-cause mortality, EQ-5D-5 L, Health and care resource use. At 12 months: Semi-structured interviews with participants and practitioners |