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Completed

NCT Number: NCT04767477

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

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.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Exercise Tolerance Fatigue Fatigue Intensity Infections Lung Diseases Lung Function Nidovirales Infections Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral Quality of Life RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Virus Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidade Federal de Pernambuco

Recife, Pernambuco, 50740-560, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Maximum functional capacity

    Time frame: 12 weeks

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

  2. Submaximal functional capacity

    Time frame: 12 weeks

    Evaluated by the six-minute walk test

  3. Intensity and impact of fatigue

    Time frame: 12 weeks

    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).

Secondary outcomes

  1. Spirometry

    Time frame: 12 weeks

    Number of patients with ventilatory disorder assessed by spirometry

  2. Quality of life assessment: Short Form-36 questionnaire

    Time frame: 12 weeks

    In this questionnaire, a score of zero corresponds to the worst general health status and the one hundred best health status.

Other outcomes

  1. Perception of clinical change

    Time frame: 12 weeks

    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".

Sponsors and collaborators

Lead sponsor

Universidade Federal de Pernambuco

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 23, 2021
Registry last updated
Oct 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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