An interventional study of Home-based physical training in Long COVID and Post-acute COVID-19 Syndrome, sponsored by University of Sao Paulo. Status unknown at 1 site in Brazil. Open to participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-05-04.
Sponsored by University of Sao Paulo · Not applicable, Interventional, and Treatment
The management of the sequelae of COVID-19 is described as the next great challenge of global public health. Multiple symptoms may compose the clinical picture of these patients (eg, fatigue, dyspnea, cognitive dysfunction, myalgia and others), persisting for more than a year and frequently causing clinically important functional impairment. Thus, a clinical trial will be conducted to investigate the effects of a remotely supervised home-based exercise program on functional sequelae of patients diagnosed with the post-COVID-19 condition (also known as Long COVID).
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's planned enrollment of 94 is close to the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →University of Sao Paulo is the lead sponsor of 1,005 studies on the registry; 90 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
In addition to receive regular medical care, the physical training group will participate in a tailored home-based exercise program (remotely supervised by healthcare professionals).
Other: Home-based physical training
The control group will receive regular medical care.
Patients allocated to this group will participate in a 16-week home-based physical training program, structured in three weekly sessions of aerobic and muscle strengthening exercises (which also have components that stimulate flexibility and balance). A third of the weekly physical training sessions will be supervised via telemedicine (with video call) by a clinical exercise specialist, but all patients will have illustrated exercise booklets and a full-time remote support service available for the remaining sessions (via text or voice messages).
Change from baseline in functional fitness assessed by distance walked (m) in the six-minute walk test (6MWT) at 16 weeks.
Higher score means better outcome.
Time frame: At baseline and after 16 weeks
Change from baseline in six-minute walk work (kg.km) assessed by 6MWT at 16 weeks.
Higher score means better outcome.
Time frame: At baseline and after 16 weeks
Change from baseline in maximal inspiratory muscle strength (cmH2O) assessed by POWERbreathe device at 16 weeks.
Higher score means better outcome.
Time frame: At baseline and after 16 weeks
Change from baseline in forced vital capacity (FVC; L) assessed on spirometry at 16 weeks.
Higher score means better outcome.
Time frame: At baseline and after 16 weeks
Change from baseline in forced expiratory volume in 1 second (FEV1; L) assessed on spirometry at 16 weeks.
Higher score means better outcome.
Time frame: At baseline and after 16 weeks
Change from baseline in FEV1/FVC ratio (%) assessed on spirometry at 16 weeks.
Higher score means better outcome.
Time frame: At baseline and after 16 weeks
Change from baseline in peak expiratory flow (L/s) assessed on spirometry at 16 weeks.
Higher score means better outcome.
Time frame: At baseline and after 16 weeks
Change from baseline in peak inspiratory flow (L/s) assessed on spirometry at 16 weeks.
Higher score means better outcome.
Time frame: At baseline and after 16 weeks
Change from baseline in muscle strength (kgf) assessed by handgrip test at 16 weeks.
Higher score means better outcome.
Time frame: At baseline and after 16 weeks
Change from baseline in muscle function (number of repetitions) assessed by the 1-minute sit-to-stand test (1'STST) at 16 weeks.
Higher score means better outcome.
Time frame: At baseline and after 16 weeks
Change from baseline in functional symptom burden (arb. unit) assessed by a weekly composite at 16 weeks.
Higher score means worse outcome.
Time frame: At baseline and after 16 weeks
Change from baseline in functional capacity (from 0 to 4 degrees of functional limitation) assessed by the post-COVID-19 functional status (PCFS) scale at 16 weeks.
Higher score means worse outcome.
Time frame: At baseline and after 16 weeks
Change from baseline in physical activity levels (min/week of MVPA) assessed by the international physical activity questionnaires (IPAQ) at 16 weeks.
Higher score means better outcome.
Time frame: At baseline and after 16 weeks
Change from baseline in fatigue levels (from 0 to 33 points) assessed by the Chalder fatigue scale (CFQ) at 16 weeks.
Higher score means worse outcome.
Time frame: At baseline and after 16 weeks
Change from baseline in executive functions (z-score) assessed in a battery of cognitive tests at 16 weeks.
Higher score means better outcome.
Time frame: At baseline and after 16 weeks
Change from baseline in learning and memory (z-score) assessed in a battery of cognitive tests at 16 weeks.
Higher score means better outcome.
Time frame: At baseline and after 16 weeks
Change from baseline in total body weight (kg) at 16 weeks.
Higher score means worse outcome.
Time frame: At baseline and after 16 weeks
Change from baseline in waist circumference (cm) at 16 weeks.
Higher score means worse outcome.
Time frame: At baseline and after 16 weeks
Change from baseline in hip circumference (cm) at 16 weeks.
Higher score means worse outcome.
Time frame: At baseline and after 16 weeks
This study is status unknown, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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University of Sao Paulo