Pulmonary Tele-rehabilitation and Progressive Muscle Relaxation on Discharged Covid-19 Patients

Effect of Pulmonary Tele-rehabilitation With and Without Progressive Muscle Relaxation Program in Covid-19 Patients After Hospital Discharge: Randomized Clinical Trial

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

Study Overview

• Status: Completed
• Conditions: Covid19
• Intervention / Treatment: Other: Pulmonary telerehabilitation; Other: progressive muscle relaxation training

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.

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of
    • Iran University of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: pulmonary telerehabilitation plus progressive muscle relaxation training; This group will perform six week pulmonary rehabilitation program and progressive muscle relaxation exercise at theirs home, with two supervised sessions by physiotherapist per week via videoconferencing.	Other: Pulmonary telerehabilitation; pulmonary telerehabilitation program include breathing exercise,aerobics exercise and upper and lower limbs muscle strengthening exercise; Other: progressive muscle relaxation training; summarized Jacobson progressive muscle relaxation training method
Active Comparator: pulmonary telerehabilitation; This group will perform six week pulmonary rehabilitation program at theirs home, with two supervised sessions by physiotherapist per week via videoconferencing.	Other: Pulmonary telerehabilitation; pulmonary telerehabilitation program include breathing exercise,aerobics exercise and upper and lower limbs muscle strengthening exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional capacity	six minute walk test (6MWT)	change from baseline in 6MWT at 2 and 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
dyspnea	Borg scale, The borg scale is a self-rating tool to measure the degree of breathlessness on a scale from 0 to 10, higher score mean worse dyspnea	change from baseline in Borg scale at 2 and 6 weeks
Sleep quality	petersburg sleep quality index (PSQI), PSQI is a eighteen item scale.The total scores range is 0-21. A higher score indicates a worse sleep quality.	change from baseline in PSQI at 6 week
anxiety and depression	hospital anxiety and depression scale (HADS), HADS is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression.The total scores range is 0-21 for both depression and anxiety scores. A higher score indicates a worse depression and anxiety.	change from baseline in HADS at 6 week

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
health status	St. George's Respiratory Questionnaire (SGRQ), Three component scores are calculated for the SGRQ (symptom,activity, impact). Scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.	change from baseline in SGRQ at 6 week
fatigue	fatigue severity scale (FSS). FSS is nine item scale. the total score range is 1-7. a higher score indicates a worse fatigue severity.	change from baseline in FSS at 2 and 6 weeks
Quality of life and well-being	Quality of life will measure using SF-36 questionnaire, SF-36 is a 36 item scale.The total scores range is 0-100. A higher score indicates a better quality of life.	change from baseline in SF36 at 6 week

Collaborators and Investigators

• Sponsor: Iran University of Medical Sciences
• Investigators: Study Chair: Javad Sarrafzadeh, PhD, Department of Physiotherapy, School of Rehabilitation Sciences, Iran University of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Actual): October 30, 2021
• Study Completion (Actual): October 30, 2021

Study Registration Dates

• First Submitted: January 30, 2021
• First Submitted That Met QC Criteria: February 4, 2021
• First Posted (Actual): February 5, 2021

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 26, 2023
• Last Verified: February 1, 2023

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: 18225

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