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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04741282
• Other study ID #: 18225
• Status: Completed
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: October 30, 2021

Study information

• Verified date: February 2023
• Source: Iran University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: October 30, 2021
• Est. primary completion date: October 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Other:
• Pulmonary telerehabilitation
pulmonary telerehabilitation program include breathing exercise,aerobics exercise and upper and lower limbs muscle strengthening exercise
• progressive muscle relaxation training
summarized Jacobson progressive muscle relaxation training method

Locations

Country	Name	City	State
Iran, Islamic Republic of	Iran university of medical sciences	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Iran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Primary	Functional capacity	six minute walk test (6MWT)	change from baseline in 6MWT at 2 and 6 weeks
Secondary	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
Secondary	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
Secondary	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