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

Not Applicable

Completed

• Conditions: Covid19
• Interventions: Other: Pulmonary telerehabilitation; Other: progressive muscle relaxation training

• Registration Number: NCT04741282
• Lead Sponsor: Iran University of Medical Sciences

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.

Study Timeline

• Study First Submitted: 2021-01-30
• Study First Submitted QC: 2021-02-04
• Study First Posted: 2021-02-05
• Study Start: 2021-05-01
• Primary Completion: 2021-10-30
• Study Completion: 2021-10-30
• Status Verified: 2023-02
• Last Update Submitted: 2023-09-26
• Last Update Posted: 2023-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
pulmonary telerehabilitation	Pulmonary telerehabilitation	This group will perform six week pulmonary rehabilitation program at theirs home, with two supervised sessions by physiotherapist per week via videoconferencing.
pulmonary telerehabilitation plus progressive muscle relaxation training	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.
pulmonary telerehabilitation plus progressive muscle relaxation training	Pulmonary telerehabilitation	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.

Primary Outcome Measures

Name	Time	Method
Functional capacity	change from baseline in 6MWT at 2 and 6 weeks	six minute walk test (6MWT)

Secondary Outcome Measures

Name	Time	Method
Sleep quality	change from baseline in PSQI at 6 week	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.
dyspnea	change from baseline in Borg scale at 2 and 6 weeks	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
anxiety and depression	change from baseline in HADS at 6 week	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.

Trial Locations

Locations (1)

Iran university of medical sciences; 🇮🇷 Tehran, Iran, Islamic Republic of