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

Primary Purpose

Covid19

Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Pulmonary telerehabilitation
progressive muscle relaxation training
Sponsored by
Iran University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Covid19

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Iran university of medical sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

pulmonary telerehabilitation plus progressive muscle relaxation training

pulmonary telerehabilitation

Arm Description

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.

This group will perform six week pulmonary rehabilitation program at theirs home, with two supervised sessions by physiotherapist per week via videoconferencing.

Outcomes

Primary Outcome Measures

Functional capacity
six minute walk test (6MWT)

Secondary Outcome Measures

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
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.
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.

Full Information

First Posted
January 30, 2021
Last Updated
September 26, 2023
Sponsor
Iran University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04741282
Brief Title
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
October 30, 2021 (Actual)
Study Completion Date
October 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Iran University of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
pulmonary telerehabilitation plus progressive muscle relaxation training
Arm Type
Experimental
Arm Description
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.
Arm Title
pulmonary telerehabilitation
Arm Type
Active Comparator
Arm Description
This group will perform six week pulmonary rehabilitation program at theirs home, with two supervised sessions by physiotherapist per week via videoconferencing.
Intervention Type
Other
Intervention Name(s)
Pulmonary telerehabilitation
Intervention Description
pulmonary telerehabilitation program include breathing exercise,aerobics exercise and upper and lower limbs muscle strengthening exercise
Intervention Type
Other
Intervention Name(s)
progressive muscle relaxation training
Intervention Description
summarized Jacobson progressive muscle relaxation training method
Primary Outcome Measure Information:
Title
Functional capacity
Description
six minute walk test (6MWT)
Time Frame
change from baseline in 6MWT at 2 and 6 weeks
Secondary Outcome Measure Information:
Title
dyspnea
Description
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
Time Frame
change from baseline in Borg scale at 2 and 6 weeks
Title
Sleep quality
Description
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.
Time Frame
change from baseline in PSQI at 6 week
Title
anxiety and depression
Description
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.
Time Frame
change from baseline in HADS at 6 week
Other Pre-specified Outcome Measures:
Title
health status
Description
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.
Time Frame
change from baseline in SGRQ at 6 week
Title
fatigue
Description
fatigue severity scale (FSS). FSS is nine item scale. the total score range is 1-7. a higher score indicates a worse fatigue severity.
Time Frame
change from baseline in FSS at 2 and 6 weeks
Title
Quality of life and well-being
Description
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.
Time Frame
change from baseline in SF36 at 6 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Javad Sarrafzadeh, PhD
Organizational Affiliation
Department of Physiotherapy, School of Rehabilitation Sciences, Iran University of Medical Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Iran university of medical sciences
City
Tehran
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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