Patients with Long Covid who were not hospitalised with their acute infection. Infections and Infestations
Conditions
Interventions
Randomisation will be generated through online randomisation software ‘Sealed Envelope’ (https:// www.sealedenvelope.com), using block randomisation with stratified blocks of six participants. Researc
Sponsors
University Hospitals of Leicester NHS Trust
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Over the age of 18 years old 2. NOT admitted to hospital during the acute phase of their Covid infection (if a patient attended accident and emergency care for medical assessment, they will still be eligible to take part) 3. Have a clinician diagnosis of Long Covid (from a dedicated Long Covid Assessment Clinic). The acute Covid-19 does not require PCR confirmation 4. Have ongoing symptoms that may be modifiable by a rehabilitation programme 5. Are willing and able to provide informed consent
Exclusion criteria
Exclusion criteria: 1. Exercise is contraindicated as outlined in the American College of Sports Medicine guidance (American College of Sports, 2022) 2. Further investigation / management for an unstable comorbidity is required 3. Exercise based rehabilitation has been attended / completed in the preceding 6 months 4. Hospital admission was required during their most recent acute SARS-Cov-2 infection 5. Severe debilitating fatigue (home bound or bed bound) that worsens with activity is experienced – regardless of formal post-exertional malaise/Myalgic Encephalomyelitis (ME) diagnosis 6. Not willing or unable to provide consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximal exercise tolerance as measured by absolute change in ISWT distance after the intervention phase. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Acceptability is measured using quantitative completion rates at 75% of scheduled sessions or follow-up assessment at baseline and follow-up 2. Acceptability is measured using qualitative focus groups with completers and semi-structured interviews with decliners and drop-outs at follow-up 3. Physical function is measured using the Short Physical Performance Battery (SPPB) at baseline and follow-up 4. Maximum isometric quadriceps strength is measured using a dynamometer (Edwards et al., 1977) at baseline and follow-up 5. Physical activity is measured using the ActiGraph accelerometer device (daily step count) at baseline and follow-up 6. Endurance exercise capacity is measured using the Endurance Shuttle Walk Test (ESWT) at baseline and follow-up 7. Generic HRQoL is measured using the EQ-5D-5L at baseline and follow-up 8. Covid-specific HRQoL is measured using the Modified C19-YRS at baseline and follow-up 9. Depression is measured using the Patient Health Questionnaire (PHQ9) at baseline and follow-up 10. Anxiety is measured using the Generalised Anxiety Disorder 7-item scale (GAD7) at baseline and follow-up 11. Breathlessness is measured using the MRC Dyspnoea scale at baseline and follow-up 12. Fatigue is measured using the Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-Fatigue) at baseline and follow-up 13. Cognitive function is measured using the Montreal Cognitive Assessment (MoCA) at baseline and follow-up 14. Post Exertional Malaise is measured using the DePaul Symptom Questionnaire Short Form (DSQ-SF) at baseline and follow-up 15. Markers of immune ageing are measured using blood samples at baseline and 6 weeks 16. Heart rate variability is measured using a 12-lead ECG NORAV Holter device continuously for 24 hours before and after the intervention period, and resting 12-lead ECG recordings for 10 minutes at baseline and after the intervention | — |
Countries
England, United Kingdom
Contacts
Public ContactKate Kontou
Outcome results
None listed