None listed
Conditions
Brief summary
The primary objective of the Post-COVID Early Rehabilitation Trial is: To determine whether a 4-week telerehabilitation program for people post hospital discharge or who were managed in the community and who have persistent symptoms following COVID-19 infection, improves physical function and symptoms compared to usual medical care. The hypothesis is that people who receive a four-week telerehabilitation program post COVID infection, will improve physical function and symptoms more than those who receive usual medical care. People who meet the inclusion criteria will be invited to participate in a study comparing a 4-week, twice weekly, program of telerehabilitation with 4-weeks of usual medical care. Following consent and initial assessment of physical function, quality of life, symptoms, anxiety, depression, and cognition, participants will be randomised using stratification for sex (male/female) and age (less than or equal to 50 years or > 50 years). At the end of the 4 weeks all participants will be reassessed by an assessor blind to group allocation. The participants will be asked not to divulge to the assessor the group to which they were allocated, and the assessor will be asked not to seek this information. All the same measures taken at initial assessment will be repeated. Participants originally randomised to the control group of usual care will be invited to crossover into the intervention group of telerehabilitation. All the same assessments will be repeated at the end of the telerehabilitation period by an assessor blind to group allocation. All participants will be invited for follow-up assessment at 12-months after completion of the intervention or control periods to assess the longer term outcomes. At this timepoint all the same assessments will be repeated and one additional questionnaire to collect information about return-to-work. A random sample of people randomised into the telerehabilitation group will be invited to participate in a focussed interview to gain an in-depth understanding of their experiences of the telerehabilitation. It is anticipated that 20 people will be interviewed or until no new themes emerge.
Interventions
The intervention group will receive pulmonary rehabilitation via telehealth supervised twice per week for 4 weeks by a physiotherapist experienced in exercise rehabilitation via remote supervision (telerehabilitation). All participants in this group will meet individually via videoconference with the physiotherapist for their first session so that any issues with the safety of the home environment can be addressed and an individualised exercise program can be prescribed and tested.
Aerobic exer
The intervention group will receive pulmonary rehabilitation via telehealth supervised twice per week for 4 weeks by a physiotherapist experienced in exercise rehabilitation via remote supervision (telerehabilitation). All participants in this group will meet individually via videoconference with the physiotherapist for their first session so that any issues with the safety of the home environment can be addressed and an individualised exercise program can be prescribed and tested. Aerobic exercise training will be walking and calisthenics of a prescribed intensity of maintaining breathlessness or fatigue (whichever is the highest) at 3 (moderate) to 4 (somewhat severe) on the 0-10 category ratio scale (Borg 1998). Strength training will be using body weight (squats, sit-to-stand, hand weights [cans of food, bags of rice etc] or resistance bands). The exercise program will be in groups no greater than 4-5 participants who will all be visible on the computer screen. The exercise session will be for 40 minutes. Before commencing exercise, participants will be asked to self-check if they have any change in how they feel or any new symptoms and to inform the physiotherapist supervising the session. Participants will be advised to stop exercise if they have any concerns or experience a change in symptoms or if the exercise causes ‘severe’ breathlessness or fatigue. At the next session, participants will be asked to report how they felt after the exercise, especially about their levels of breathlessness and feelings of fatigue. If fatigue was worse, the exercises will be adjusted to be a lower intensity or more rests will be included. An Australian case series of post-COVID patients has demonstrated that rehabilitation via videoconferencing was feasible and safe (Wootton et al, 2020). Adherence to the exercise sessions will be monitored by recording attendance at the telerehabilitation sessions. An education program will be provided for 30 minutes once a week at the conclusion of the exercise session. Education sessions will include strategies to manage fatigue; eating well; managing daily activities; staying physically active; managing anxiety and depression; and return to work. The education will be provided by the physiotherapist and will be based on the World Health Organisation’s Pamphlet Support for rehabilitation: self-management after COVID-19-related illness (WHO 2021).
Sponsors
Sydney Local Health District
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. People diagnosed with COVID-19 who were hospitalised due to the severity of their COVID-19 infection and who attend a Post-COVID Respiratory Clinic at RPAH or Concord Hospital or people diagnosed with COVID-19 and who were managed in the community, either at home or by virtual care. 2. Ongoing symptoms consistent with post-COVID sequelae 3. Sex: All genders 4. Age range: greater than or equal to 18 years old 5. Identified by treating physician as suitable for rehabilitation 6. Willingness to provide informed consent and willingness to participate and comply with the study requirements.
Exclusion criteria
1. People with severe COVID-19 requiring long stay ICU who develop post-ICU syndrome. These people need rehabilitation and therefore should not be in a RCT in which they may be randomised to no rehabilitation. 2. People with acute symptoms of any illness where exercise is not recommended 3. People who are not medically stable as judged by treating physician 4. Women who are pregnant or post-partum 5. No access to appropriate technology (e.g internet, computer or tablet) 6. Difficulty understanding English and unable to access an interpreter 7. Severe cognitive impairment or other comorbidities which would make exercise unsafe, as assessed by the referring physician
Outcome results
None listed