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

NCT04767477 | Completed DMC

• 1 other identifier: CR and TR
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Covid19; Exercise Tolerance; Quality of Life; Lung Function; Fatigue Intensity

Outcome Measures

Primary Outcomes (3)

• Maximum functional capacity

  Evaluated by the cardiopulmonary exercise test by measuring the maximum oxygen consumption

  12 weeks

• Submaximal functional capacity

  Evaluated by the six-minute walk test

  12 weeks

• 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 Outcomes (2)

• Spirometry

  12 weeks

• Quality of life assessment: Short Form-36 questionnaire

  12 weeks

Other Outcomes (1)

• Perception of clinical change

  12 weeks

Study Arms (1)

Face-to-face rehabilitation and Telerehabilitation

OTHER

The Face-to-face rehabilitation and Telerehabilitation protocol will consist of flexibility exercises, aerobic and resistance training, with two sessions per week.

Other: Face-to-face rehabilitation; Other: Telerehabilitation

Interventions

Face-to-face rehabilitation OTHER

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.

Face-to-face rehabilitation and Telerehabilitation

Telerehabilitation OTHER

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.

Face-to-face rehabilitation and Telerehabilitation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Federal de Pernambuco: lead

Study Sites (1)

Universidade Federal de Pernambuco

Recife, Pernambuco, 50740-560, Brazil

Location

MeSH Terms

Conditions

COVID-19; Fatigue

Interventions

Telerehabilitation

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: physiotherapist

Study Record Dates

• First Submitted: December 21, 2020
• First Posted: February 23, 2021
• Study Start: March 28, 2021
• Primary Completion: August 31, 2021
• Study Completion: September 10, 2021
• Last Updated: October 5, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)