Clinical trial NCT04741282: Pulmonary Tele-rehabilitation and Progressive Muscle Relaxation on Discharged Covid-19 Patients
Official title: Effect of Pulmonary Tele-rehabilitation With and Without Progressive Muscle Relaxation Program in Covid-19 Patients After Hospital Discharge: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Lead sponsor: Iran University of Medical Sciences
Sponsor class: OTHER
First posted: 2021-02-05
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to investigate efficacy of internet based pulmonary rehabilitation and progressive muscle relaxation program on functional capacity, depression and anxiety, dyspnea, fatigue, sleep quality and quality of life in covid19 patients after hospital discharge

Detailed description: Novel coronavirus disease 2019 (covid19) could cause respiratory and physical dysfunction, anxiety and depression, fatigue and affect sleep quality and quality of life in infected patient after hospital discharge. there is expect that pulmonary rehabilitation can improve these symptoms and prevent complications in these cases. It seems that Progressive muscle relaxation exercise could improve pulmonary rehabilitation effect. Due to social isolation of Covid 19 patients after hospital discharge, internet base rehabilitation will be used in this study. participants will be randomized in two pulmonary tele-rehabilitation groups after hospital discharge. One group will be received pulmonary rehabilitation include education, breathing exercises, aerobic and upper and lower limbs muscle strengthening exercises. Another group will be perform progressive muscle relaxation in addition of these exercise. Treatment duration is 6 week with 5 days/week frequency. Two exercise sessions per week will be supervised with expert physiotherapist via videoconferencing.

Outcomes will be measured at baseline, within two week and at the end of six week exercises program.

Eligibility criteria: Inclusion Criteria:

* Covid 19 patient that confirmed with polymerase chain reaction test (PCR)
* Hospitalized Corvid 19 patients after discharge
* Accessibility to internet and using video call

Exclusion Criteria:

* Mental and physical disability
* Uncontrolled cardiac dysfunction such as arrhythmia
* Sever neurological condition such as guillain-barre and stroke
* Uncontrolled diabetes or blood pressure
* Pregnant women
* Re-hospitalization during treatment program
* Chronic pulmonary and kidney condition

Primary outcomes:
measure: Functional capacity
timeFrame: change from baseline in 6MWT at 2 and 6 weeks
Secondary outcomes:
measure: dyspnea
timeFrame: change from baseline in Borg scale at 2 and 6 weeks
measure: Sleep quality
timeFrame: change from baseline in PSQI at 6 week
measure: anxiety and depression
timeFrame: change from baseline in HADS at 6 week
Other outcomes:
measure: health status
timeFrame: change from baseline in SGRQ at 6 week
measure: fatigue
timeFrame: change from baseline in FSS at 2 and 6 weeks
measure: Quality of life and well-being
timeFrame: change from baseline in SF36 at 6 week
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Iran university of medical sciences
Study officials:
affiliation: Department of Physiotherapy, School of Rehabilitation Sciences, Iran University of Medical Sciences
name: Javad Sarrafzadeh, PhD
role: STUDY_CHAIR
References: