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Table 1 World Health Organization Trial Registration Data Set

From: Supervised pulmonary hypertension exercise rehabilitation (SPHERe): study protocol for a multi-centre randomised controlled trial

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
Email: gordon.mcgregor@warwick.ac.uk
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
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