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

Primary Purpose

Covid19, Exercise Tolerance, Quality of Life

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Face-to-face rehabilitation
Telerehabilitation
Sponsored by
Universidade Federal de Pernambuco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Universidade Federal de Pernambuco

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Face-to-face rehabilitation and Telerehabilitation

Arm Description

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

Outcomes

Primary Outcome Measures

Maximum functional capacity
Evaluated by the cardiopulmonary exercise test by measuring the maximum oxygen consumption
Submaximal functional capacity
Evaluated by the six-minute walk test
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).

Secondary Outcome Measures

Spirometry
Number of patients with ventilatory disorder assessed by spirometry
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.

Full Information

First Posted
December 21, 2020
Last Updated
October 4, 2021
Sponsor
Universidade Federal de Pernambuco
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1. Study Identification

Unique Protocol Identification Number
NCT04767477
Brief Title
Telerehabilitation and Face-to-face Rehabilitation on COVID-19 Survivors
Official Title
Telerehabilitation and Face-to-face Rehabilitation on Tolerance to Exercise and Quality of Life of COVID-19 Survivors: a Study Protocol
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
March 28, 2021 (Actual)
Primary Completion Date
August 31, 2021 (Actual)
Study Completion Date
September 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal de Pernambuco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, Exercise Tolerance, Quality of Life, Lung Function, Fatigue Intensity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Face-to-face rehabilitation and Telerehabilitation
Arm Type
Other
Arm Description
The Face-to-face rehabilitation and Telerehabilitation protocol will consist of flexibility exercises, aerobic and resistance training, with two sessions per week.
Intervention Type
Other
Intervention Name(s)
Face-to-face rehabilitation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Telerehabilitation
Intervention Description
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 Outcome Measure Information:
Title
Maximum functional capacity
Description
Evaluated by the cardiopulmonary exercise test by measuring the maximum oxygen consumption
Time Frame
12 weeks
Title
Submaximal functional capacity
Description
Evaluated by the six-minute walk test
Time Frame
12 weeks
Title
Intensity and impact of fatigue
Description
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).
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Spirometry
Description
Number of patients with ventilatory disorder assessed by spirometry
Time Frame
12 weeks
Title
Quality of life assessment: Short Form-36 questionnaire
Description
In this questionnaire, a score of zero corresponds to the worst general health status and the one hundred best health status.
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Perception of clinical change
Description
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".
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Universidade Federal de Pernambuco
City
Recife
State/Province
PE
ZIP/Postal Code
50740-560
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

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

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