Improving the experience of physical activity in people with severe lung disease using dietary nitrate supplementation with beetroot juice

Dietary nitrate supplementation to enhance daily physical activity in hypoxic COPD: A randomised controlled trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN12474100

Enrollment

102

Registered

2022-08-02

Start date

2022-09-01

Completion date

Unknown

Last updated

2025-01-06

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

Conditions

Chronic obstructive pulmonary disease Respiratory

Interventions

On-PACE is a double-blind parallel-group randomised controlled trial to demonstrate the superiority of dietary nitrate supplementation with beetroot juice to matched placebo conducted at a single cent

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adults aged 18 years and over 2. Diagnosis of COPD 3. Under care of home oxygen service 4. Documented oxygen assessment meeting NICE criteria: 4.1. PaO2< 7.3 or < 8 if pulmonary hypertension 4.2. Increase in exercise capacity if ambulatory oxygen only

Exclusion criteria

Exclusion criteria: 1. Inability to consent 2. Systolic blood pressure below 120mmHg 3. Exacerbation within the last four weeks 4. Use of nitrate-based medication

Design outcomes

Primary

Measure	Time frame
Experience of difficulty with physical activity measured using the difficulty domain of the clinic visit PROactive COPD tool, c-PPAC, at baseline and 3 months	—

Secondary

Measure	Time frame
Current secondary outcome measures as of 28/05/2024: 1. Experience of the amount of physical activity measured using the amount domain of the clinic visit PROactive COPD tool, c-PPAC, at baseline and 3 months 2. Exercise capacity measured using an endurance shuttle walk test (ESWT) at baseline and 3 months 3. Oxygenation and heart rate during exercise measured using a pulse oximeter during ESWT at baseline and 3 months 4. Mean arterial pressure, reactive hyperaemia index (RHI) and PAT-Augmentation Index (AI@75) measured using an EndoPAT-RHI system (Itamar Medical) at baseline and 3 months 5. Step count/day measured using a Mcroberts MoveMonitor worn for 7 days at baseline and 3 months 6. Quality of life measured using both COPD assessment (CAT) score and EQ-5D-5L questionnaire at baseline and 3 months 7. Fatigue measured using the FACIT score at baseline and 3 months 8. BNP, blood nitrite/nitrate levels and other blood markers of endothelial function (ADMA, Endothelin 1, Prostacyclin) measured using blood sampling and analysis (including ECFC isolation (alternatively named BOEC) and neutrophil isolation) at baseline and 3 months _____ Previous secondary outcome measures: 1. Experience of the amount of physical activity measured using the amount domain of the clinic visit PROactive COPD tool, c-PPAC, at baseline and 3 months 2. Exercise capacity measured using an endurance shuttle walk test (ESWT) at baseline and 3 months 3. Oxygenation and heart rate during exercise measured using a pulse oximeter during ESWT at baseline and 3 months 4. Mean arterial pressure, reactive hyperaemia index (RHI) and PAT-Augmentation Index (AI@75) measured using an EndoPAT-RHI system (Itamar Medical) at baseline and 3 months 5. Step count/day measured using a Mcroberts MoveMonitor worn for 7 days at baseline and 3 months 6. Quality of life measured using both COPD assessment (CAT) score and EQ-5D-5L questionnaire at baseline and 3 months 7. Fatigue measured using the FACIT score at	—

Measure

Time frame

Current secondary outcome measures as of 28/05/2024: 1. Experience of the amount of physical activity measured using the amount domain of the clinic visit PROactive COPD tool, c-PPAC, at baseline and 3 months 2. Exercise capacity measured using an endurance shuttle walk test (ESWT) at baseline and 3 months 3. Oxygenation and heart rate during exercise measured using a pulse oximeter during ESWT at baseline and 3 months 4. Mean arterial pressure, reactive hyperaemia index (RHI) and PAT-Augmentation Index (AI@75) measured using an EndoPAT-RHI system (Itamar Medical) at baseline and 3 months 5. Step count/day measured using a Mcroberts MoveMonitor worn for 7 days at baseline and 3 months 6. Quality of life measured using both COPD assessment (CAT) score and EQ-5D-5L questionnaire at baseline and 3 months 7. Fatigue measured using the FACIT score at baseline and 3 months 8. BNP, blood nitrite/nitrate levels and other blood markers of endothelial function (ADMA, Endothelin 1, Prostacyclin) measured using blood sampling and analysis (including ECFC isolation (alternatively named BOEC) and neutrophil isolation) at baseline and 3 months _____ Previous secondary outcome measures: 1. Experience of the amount of physical activity measured using the amount domain of the clinic visit PROactive COPD tool, c-PPAC, at baseline and 3 months 2. Exercise capacity measured using an endurance shuttle walk test (ESWT) at baseline and 3 months 3. Oxygenation and heart rate during exercise measured using a pulse oximeter during ESWT at baseline and 3 months 4. Mean arterial pressure, reactive hyperaemia index (RHI) and PAT-Augmentation Index (AI@75) measured using an EndoPAT-RHI system (Itamar Medical) at baseline and 3 months 5. Step count/day measured using a Mcroberts MoveMonitor worn for 7 days at baseline and 3 months 6. Quality of life measured using both COPD assessment (CAT) score and EQ-5D-5L questionnaire at baseline and 3 months 7. Fatigue measured using the FACIT score at

—

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 9, 2026