Covid19NCT04741282
Pulmonary Tele-rehabilitation and Progressive Muscle Relaxation on Discharged Covid-19 Patients
A study testing Pulmonary telerehabilitation and progressive muscle relaxation training in people with Covid19, run by Iran University of Medical Sciences at 1 site in Iran.
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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Covid19
- What is being tested?
- Pulmonary telerehabilitation and progressive muscle relaxation training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteIran
- Study dates
- 1 May 2021to 30 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Covid 19 patient that confirmed with polymerase chain reaction test (PCR)
- Hospitalized Corvid 19 patients after discharge
- Accessibility to internet and using video call
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Covid19
- Being tested
- Pulmonary telerehabilitation, progressive muscle relaxation training
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary telerehabilitationOther
pulmonary telerehabilitation program include breathing exercise,aerobics exercise and upper and lower limbs muscle strengthening exercise
progressive muscle relaxation trainingOther
summarized Jacobson progressive muscle relaxation training method
| Study group | Role | What they receive |
|---|---|---|
| pulmonary telerehabilitation plus progressive muscle relaxation training | Experimental | 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. Receives: Other: Pulmonary telerehabilitation; Other: progressive muscle relaxation training |
| pulmonary telerehabilitation | Active comparator | This group will perform six week pulmonary rehabilitation program at theirs home, with two supervised sessions by physiotherapist per week via videoconferencing. Receives: Other: Pulmonary telerehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional capacity
six minute walk test (6MWT)
Measured: change from baseline in 6MWT at 2 and 6 weeks
Secondary outcomes (3)
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
Measured: 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.
Measured: 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.
Measured: change from baseline in HADS at 6 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2021
- Study start1 May 2021
- Primary completion30 Oct 2021
- Study completion30 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Javad Sarrafzadeh, PhD, Study chair, Department of Physiotherapy, School of Rehabilitation Sciences, Iran University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04741282
- Sponsor's protocol ID
- 18225
- Status last verified
- Feb 2023
- First submitted
- 30 Jan 2021
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pulmonary Tele-rehabilitation With and Without Progressive Muscle Relaxation Program in Covid-19 Patients After Hospital Discharge: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04741282
- Acronym / sponsor ID
- 18225
- Conditions
- Covid19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Iran University of Medical SciencesUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 30 Oct 2021 (actual)
- Study completion
- 30 Oct 2021 (actual)
- First posted
- 5 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pulmonary telerehabilitation plus progressive muscle relaxation training | Experimental | Other: Pulmonary telerehabilitation, Other: progressive muscle relaxation trainingThis 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 | Active comparator | Other: Pulmonary telerehabilitationThis group will perform six week pulmonary rehabilitation program at theirs home, with two supervised sessions by physiotherapist per week via videoconferencing. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Covid 19 patient that confirmed with polymerase chain reaction test (PCR)
- Hospitalized Corvid 19 patients after discharge
- Accessibility to internet and using video call
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulmonary telerehabilitationpulmonary telerehabilitation program include breathing exercise,aerobics exercise and upper and lower limbs muscle strengthening exercise | Other | pulmonary telerehabilitation, pulmonary telerehabilitation plus progressive muscle relaxation training |
| progressive muscle relaxation trainingsummarized Jacobson progressive muscle relaxation training method | Other | pulmonary telerehabilitation plus progressive muscle relaxation training |
Primary outcome
Functional capacity
Time frame: change from baseline in 6MWT at 2 and 6 weeks
six minute walk test (6MWT)
3 secondary outcomes
dyspnea
Time frame: change from baseline in Borg scale at 2 and 6 weeks
Sleep quality
Time frame: change from baseline in PSQI at 6 week
anxiety and depression
Time frame: change from baseline in HADS at 6 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Javad Sarrafzadeh, PhD study chair
Department of Physiotherapy, School of Rehabilitation Sciences, Iran University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary telerehabilitation and progressive muscle relaxation training in people with Covid19, run by Iran University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional capacity (time frame: change from baseline in 6MWT at 2 and 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.