Clinical trial NCT04895371: Tele-Physiotherapy After COVID-19 Hospitalization
Official title: The Efficacy of Tele-Physiotherapy in Patients After COVID-19 Hospitalization: The PPTCOVID Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Coronavirus Disease 2019
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2021-05-20
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The participants will be randomly allocated to Tele-physiotherapy or control groups.

The sample size was calculated to identify clinically relevant effects on the primary outcome, the distance of six-minute walk test. The calculation was performed using STATA 16 software. Presuming a two-sided significance level (α) of 0.05, the power of 80% (β=0.20) and standard deviation based on the results of a relevant study in COVID-19 survivors which assessed the distance of six-minute walk test. Minimal clinically important difference (MCID) of 54m was reported and considered to be clinically significant. Repeated measurement of ANCOVA was used for the calculation with a baseline and two follow-up measurements (correlation of repeated measurement=0.499). After considering 20% possible participants attrition, It was determined that a sample size of 72 participants would be required to detect a significant change, 36 in each group.
Primary purpose: TREATMENT

Brief summary: Coronavirus disease 2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2), is a multisystem infectious disease which has led to a global pandemic.

Tele-medicine is a tool to connect patients and health care professions while maintaining social distancing and restrictions. Tele-physiotherapy is a field of physiotherapy which has the advantage of providing therapy.

Since some months ago, different organizations have started the tele-physiotherapy/tele-rehabilitation program to manage the patients' complications after COVID-19. This research team have developed a tele-rehabilitation guideline for physiotherapists to help them how to use tele-physiotherapy program for patients after COVID-19 hospitalization. The aim of this study is to evaluate the efficacy of tele-physiotherapy program in patients discharged after COVID-19.

Detailed description: Coronavirus disease 2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2), is a multisystem infectious disease which has led to a global pandemic.

Due to multisystem nature of this disease, it can cause a variety of early and late complications. New studies have revealed some of the long-term sequelae of this disease, such as neurological injuries, arterial or venous thrombosis, cardiac, brain strokes, etc. which need to be taken into consideration during management of patients. Many COVID-19 survivors who require critical care may also develop psychological, physical and cognitive impairments. These patients may develop various impairments because of hospitalization owing to extended immobilization and many hours bed ridden; these include neuromuscular complications, severe muscle weakness and fatigue, joint stiffness, dysphagia, psychological problems, reduced mobility, low quality of life, frequent falls, and even quadriparesis.

Given impacts of COVID-19 on global health care system, innovative approaches in managing patients are needed. This is the reason that tele-medicine is becoming a trendy title for researchers . Tele-medicine is a tool to connect patients and health care professions while maintaining social distancing and restrictions . Digital health interventions can help provide self-monitoring tools, field updates, exercise protocols, and psychological support. Depending on the funding and facilities provided by the health care system, tele-medicine can be designed and employed in each country uniquely.

Physiotherapy interventions can be also delivered through modern digital communication tools. Tele-physiotherapy is a field of physiotherapy which has the advantage of providing therapy wherever is most convenient for the patient through the use of modern digital communication.

Based on the evidences from other outbreak of viruses in the coronavirus strain epidemics, many of the discharged patients after COVID-19 pneumonia are likely to have residual impairment even some years after hospitalization. Not only discharged COVID-19 patients, but also other members of the society might need physiotherapy in this crisis. Despite this need, social distancing should be taken into account and human lives can't be put in danger. Tele-physiotherapy provides a great opportunity for therapists to communicate with their patients, assess and treat them.

Since some months ago, different organizations have started the tele-physiotherapy/tele-rehabilitation program to manage the patients' complications after COVID-19. This research team have developed a tele-rehabilitation guideline for physiotherapists to help them how to use tele-physiotherapy program for patients after COVID-19 hospitalization. The aim of this study is to evaluate the efficacy of tele-physiotherapy program in patients discharged after COVID-19.

Eligibility criteria: Inclusion Criteria:

* Discharged patients with Covid-19 pneumonia,
* Having at least one rT-PCR Covid test,
* Duration of hospitalization \> 10 days,
* Ability to walk,
* Totally oriented,
* Ability to use smartphone,
* Ability to read and write in Persian.

Exclusion Criteria:

* Having any kind of musculoskeletal disorder causing inability to participate in physiotherapy sessions,
* Severe cardiovascular impairments.

Primary outcomes:
measure: 6-Minute Walk Test (6MWT)
timeFrame: Baseline
measure: 6-Minute Walk Test (6MWT)
timeFrame: After six weeks
measure: 6-Minute Walk Test (6MWT)
timeFrame: After 10 weeks
Secondary outcomes:
measure: Five Times Sit to Stand test (5TST)
timeFrame: Baseline
measure: Five Times Sit to Stand test (5TST)
timeFrame: After six weeks
measure: Five Times Sit to Stand test (5TST)
timeFrame: After 10 weeks
measure: Fatigue Severity Scale (FSS)
timeFrame: Baseline
measure: Fatigue Severity Scale (FSS)
timeFrame: After six weeks
measure: Fatigue Severity Scale (FSS)
timeFrame: After 10 weeks
measure: International Physical Activity Questionnaire (IPAQ)
timeFrame: Baseline
measure: International Physical Activity Questionnaire (IPAQ)
timeFrame: After six weeks
measure: International Physical Activity Questionnaire (IPAQ)
timeFrame: After 10 weeks
measure: Level of dyspnea
timeFrame: Baseline
measure: Level of dyspnea
timeFrame: After six weeks
measure: Level of dyspnea
timeFrame: After 10 weeks
measure: Short From-36
timeFrame: Baseline
measure: Short From-36
timeFrame: After six weeks
measure: Short From-36
timeFrame: After 10 weeks
measure: Strength of shoulder abduction muscle group
timeFrame: Baseline
measure: Strength of shoulder abduction muscle group
timeFrame: After six weeks
measure: Strength of shoulder abduction muscle group
timeFrame: After 10 weeks
measure: Strength of hip abduction muscle group
timeFrame: Baseline
measure: Strength of hip abduction muscle group
timeFrame: After six weeks
measure: Strength of hip abduction muscle group
timeFrame: After 10 weeks
measure: Strength of knee extension muscle group
timeFrame: Baseline
measure: Strength of knee extension muscle group
timeFrame: After six weeks
measure: Strength of knee extension muscle group
timeFrame: After 10 weeks
measure: Strength of elbow flexion muscle group
timeFrame: Baseline
measure: Strength of elbow flexion muscle group
timeFrame: After six weeks
measure: Strength of elbow flexion muscle group
timeFrame: After 10 weeks
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Imam Khomeini Hospital Complex
Study officials:
affiliation: Tehran University of Medical Sciences
name: Mohammad Javaherian, Ph.D. cand.
role: PRINCIPAL_INVESTIGATOR
affiliation: Tehran University of Medical Sciences
name: Mohsen Nasiri-toosi, MD.
role: STUDY_DIRECTOR
affiliation: Tehran University of Medical Sciences
name: Behrouz Attarbashi Moghadam, Ph.D.
role: STUDY_DIRECTOR
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