Supervised Pulmonary Hypertension Exercise REhabilitation (SPHERe) trial

Supervised Pulmonary Hypertension Exercise REhabilitation (SPHERe): a multi-centre randomized controlled trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN10608766

Enrollment

200

Registered

2019-03-18

Start date

2021-06-16

Completion date

Unknown

Last updated

2024-08-05

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

Conditions

Pulmonary hypertension Circulatory System Primary pulmonary hypertension

Interventions

Current interventions as of 29/03/2021: Participants will be randomly allocated to either remotely supervised exercise with psychological and motivational support, or best-practice usual care (general

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Current inclusion criteria as of 29/03/2021: 1. Adults with confirmed PH (groups 1 to 5) as detailed in ESC/ERS guidelines 2. Clinically stable 3. World Health Organisation (WHO) functional class II, III or IV 4. Fluent in spoken English to allow engagement with intervention and physical outcome measures 5. Live within reasonable travelling distance (as defined by the participant) of a SPHERE exercise rehabilitation centre (outcome assessments only) 6. Ability to provide informed consent 7. Access to appropriate IT infrastructure (computer, laptop, tablet, smart phone, email and internet connection) 8. Ability to make suitable travel arrangements to attend clinic (outcome assessments only) Previous inclusion criteria: 1. Adults with confirmed PH (groups 1 to 5) as detailed in ESC/ERS guidelines 2. Clinically stable 3. World Health Organisation (WHO) functional class II, III or IV 4. Fluent in spoken English to allow engagement with intervention and physical outcome measures 5. Live within reasonable travelling distance (as defined by the participant) of a SPHERE exercise rehabilitation centre 6. Ability to provide informed consent

Exclusion criteria

Exclusion criteria: Current exclusion criteria as of 29/03/2021: 1. Absolute contraindications to exercise as per international clinical guidelines 2. PH related complications, or comorbidities severe enough to prevent attendance at a SPHERE centre, or participation in exercise rehabilitation 3. Any mental health issue that will prevent engagement with study procedures 4. Previous randomisation in the present trial 5. Pregnancy at the time of recruitment Previous exclusion criteria: 1. Absolute contraindications to exercise as per international clinical guidelines 2. PH related complications, or comorbidities severe enough to prevent attendance at a SPHERE centre, or participation in exercise rehabilitation 3. Any mental health issue that will prevent engagement with study procedures 4. Unable to make suitable travel arrangements 5. Previous randomisation in the present trial 6. Pregnancy

Design outcomes

Primary

Measure	Time frame
Exercise capacity measured with incremental shuttle walk test (ISWT) at 4 months.	—

Secondary

Measure	Time frame
Current secondary outcome measures as of 24/02/2023: 1. Disease-specific health-related quality of life (HR-QoL) measured with Cambridge Pulmonary Hypertension Outcome Review at 4 and 12 months 2. Health utility measured with EQ-5D-5L at 4 and 12 months 3. Emotional well-being measured with the Hospital Anxiety and Depression Scale at 4 and 12 months 4. Generalised self-efficacy measured with a psychometric scale at 4 and 12 months 5. Fatigue measured with the Fatigue Severity Scale at 4 and 12 months 6. Functional status measured using WHO functional class at 4 and 12 months 7. Self-reported medication use at 4 and 12 months 8. Time to clinical worsening measured by medical notes and discussion with a clinician at 4 and 12 months 9. Health and social care resource use measured by participant self-report and NHS data at 4 and 12 months 10. All-cause hospital admissions from GP records at 12 months 11. Adverse events measured with NHS data at 4 and 12 months 12. All-cause mortality Previous secondary outcome measures as of 29/03/2021 to 24/02/2023: 1. Exercise capacity measured with incremental shuttle walk test at 12 months 2. Disease-specific health-related quality of life (HR-QoL) measured with Cambridge Pulmonary Hypertension Outcome Review at 4 and 12 months 3. Emotional well-being measured with the Hospital Anxiety and Depression Scale at 4 and 12 months 4. Self-efficacy measured with the Generalised self-efficacy scale at 4 and 12 months 5. Fatigue measured with the Fatigue Severity Scale at 4 and 12 months 6. Functional status measured using WHO functional class at 4 and 12 months 7. Self-reported medication use at 4 and 12 months 8. Time to clinical worsening measured by medical notes and discussion with clinician at 4 and 12 months 9. Hospital admissions measured with NHS data at 4 and 12 months 10. Adverse events measured with NHS data at 4 and 12 months 11. All-cause mortality measured with NHS data at 4 and 12 months 12. Heath utility measured with EQ-5	—

Measure

Time frame

Current secondary outcome measures as of 24/02/2023: 1. Disease-specific health-related quality of life (HR-QoL) measured with Cambridge Pulmonary Hypertension Outcome Review at 4 and 12 months 2. Health utility measured with EQ-5D-5L at 4 and 12 months 3. Emotional well-being measured with the Hospital Anxiety and Depression Scale at 4 and 12 months 4. Generalised self-efficacy measured with a psychometric scale at 4 and 12 months 5. Fatigue measured with the Fatigue Severity Scale at 4 and 12 months 6. Functional status measured using WHO functional class at 4 and 12 months 7. Self-reported medication use at 4 and 12 months 8. Time to clinical worsening measured by medical notes and discussion with a clinician at 4 and 12 months 9. Health and social care resource use measured by participant self-report and NHS data at 4 and 12 months 10. All-cause hospital admissions from GP records at 12 months 11. Adverse events measured with NHS data at 4 and 12 months 12. All-cause mortality Previous secondary outcome measures as of 29/03/2021 to 24/02/2023: 1. Exercise capacity measured with incremental shuttle walk test at 12 months 2. Disease-specific health-related quality of life (HR-QoL) measured with Cambridge Pulmonary Hypertension Outcome Review at 4 and 12 months 3. Emotional well-being measured with the Hospital Anxiety and Depression Scale at 4 and 12 months 4. Self-efficacy measured with the Generalised self-efficacy scale at 4 and 12 months 5. Fatigue measured with the Fatigue Severity Scale at 4 and 12 months 6. Functional status measured using WHO functional class at 4 and 12 months 7. Self-reported medication use at 4 and 12 months 8. Time to clinical worsening measured by medical notes and discussion with clinician at 4 and 12 months 9. Hospital admissions measured with NHS data at 4 and 12 months 10. Adverse events measured with NHS data at 4 and 12 months 11. All-cause mortality measured with NHS data at 4 and 12 months 12. Heath utility measured with EQ-5

—

Countries

England, Scotland, United Kingdom, Wales

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026