Covid19 Clinical Trial
Official title:
Telerehabilitation and Face-to-face Rehabilitation on Tolerance to Exercise and Quality of Life of COVID-19 Survivors: a Study Protocol
Verified date | October 2021 |
Source | Universidade Federal de Pernambuco |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
INTRODUCTION: As this is a new disease, the short- and long-term consequences for patients with COVID-19 are still unclear. The use of sedatives, as well as prolonged rest, can lead to musculoskeletal damage, including decreased muscle strength and physical function. Thus, rehabilitation after this disease is a key component in continuing patient care. OBJECTIVE: To verify the effects of face-to-face cardiac rehabilitation and telerehabilitation on tolerance to the maximum and submaximal exercise, lung function, fatigue intensity and quality of life of COVID-19 survivors. METHODS: This is a longitudinal, intervention study. Primary outcomes will be maximum and submaximal functional capacity, intensity and impact of fatigue, while secondary outcomes will be lung function and quality of life. EXPECTED RESULTS: This work will bring important information to the scientific community and health professionals, about the best forms of intervention and its repercussions on the surviving individuals of COVID-19.
Status | Completed |
Enrollment | 26 |
Est. completion date | September 10, 2021 |
Est. primary completion date | August 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - Adults of both genders; - With a diagnosis of COVID-19 confirmed by a laboratory through RT-PCR means; - Have to access to the internet and some device (smartphone, computer or notebook) that allows them to participate in the call centre. Exclusion Criteria: - Individuals with orthopaedic or neurological diseases; - Individuals with difficulties in understanding and that present psychological changes that make it difficult or impossible to understand the information presented. |
Country | Name | City | State |
---|---|---|---|
Brazil | Universidade Federal de Pernambuco | Recife | PE |
Lead Sponsor | Collaborator |
---|---|
Universidade Federal de Pernambuco |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Perception of clinical change | Evaluated by the Patient Global Impression of Change Scale which is a one-dimensional measure in which individuals can rate their associated improvement on a 7-item scale ranging from "1 = no changes" to "7 = much better". | 12 weeks | |
Primary | Maximum functional capacity | Evaluated by the cardiopulmonary exercise test by measuring the maximum oxygen consumption | 12 weeks | |
Primary | Submaximal functional capacity | Evaluated by the six-minute walk test | 12 weeks | |
Primary | Intensity and impact of fatigue | Evaluated by the Fatigue pictogram questionnaire, an ordinal scale composed of two questions graded in 5 captioned illustrations that assess the intensity (not at all tired, a little tired, moderately tired, very tired and extremely tired) and the impact of fatigue (I manage to do everything I normally do I do, I can do almost everything I usually do, I can do some of the things I usually do, I just do what I have to do and I can do very little). | 12 weeks | |
Secondary | Spirometry | Number of patients with ventilatory disorder assessed by spirometry | 12 weeks | |
Secondary | Quality of life assessment: Short Form-36 questionnaire | In this questionnaire, a score of zero corresponds to the worst general health status and the one hundred best health status. | 12 weeks |
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