Telerehabilitation and Face-to-face Rehabilitation on COVID-19 Survivors

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04767477
• Other study ID #: CR and TR
• Status: Completed
• Phase: N/A
• Start date: March 28, 2021
• Est. completion date: September 10, 2021

Study information

• Verified date: October 2021
• Source: Universidade Federal de Pernambuco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Exercise Tolerance
• Fatigue Intensity
• Lung Function
• Quality of Life

Intervention

Other:
• Face-to-face rehabilitation
Aerobic training will be performed with 60% to 80% of the maximum VO2 obtained through the CPET. The exercise will be performed on the treadmill, with a total time of 40 minutes, with 5 minutes of warm-up, 30 minutes of conditioning, 5 minutes of cooling down. Resistance training will be performed for upper and lower limbs and the load used in the exercises will be 60% of the maximum repetition test (1RM), with load progression every six sessions. The exercises are performed in three series of 12 repetitions.
• Telerehabilitation
The telerehabilitation protocol will consist of stretching the muscles of the upper and lower limbs and accessory muscles of breathing. The conditioning phase will consist of stationary walking, side running, jumping jump and stationary running, 3 times of 40 seconds with a 30-second passive rest interval between them. Resistance training will be applied to the muscles of the upper limbs and lower limbs, with specific exercises for each musculature, using elastic bands as resistance.

Locations

Country	Name	City	State
Brazil	Universidade Federal de Pernambuco	Recife	PE

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal de Pernambuco

Country where clinical trial is conducted

Brazil, 

Outcome

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