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

Telerehabilitation and Face-to-face Rehabilitation on Tolerance to Exercise and Quality of Life of COVID-19 Survivors: a Study Protocol

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Covid19; Exercise Tolerance; Lung Function; Fatigue Intensity
• Intervention / Treatment: Other: Face-to-face rehabilitation; Other: Telerehabilitation

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • PE
    • Recife, PE, Brazil, 50740-560
      • Universidade Federal de Pernambuco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spirometry	Number of patients with ventilatory disorder assessed by spirometry	12 weeks
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Universidade Federal de Pernambuco

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2021
• Primary Completion (Actual): August 31, 2021
• Study Completion (Actual): September 10, 2021

Study Registration Dates

• First Submitted: December 21, 2020
• First Submitted That Met QC Criteria: February 22, 2021
• First Posted (Actual): February 23, 2021

Study Record Updates

• Last Update Posted (Actual): October 5, 2021
• Last Update Submitted That Met QC Criteria: October 4, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: CR and TR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No