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

Sponsor
Iran University of Medical Sciences (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04741282
Collaborator
(none)
52
Enrollment
2
Arms
8
Anticipated Duration (Months)

Study Details

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

Condition or DiseaseIntervention/TreatmentPhase
  • Other: Pulmonary telerehabilitation
  • Other: progressive muscle relaxation training
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
52 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Effect of Pulmonary Tele-rehabilitation With and Without Progressive Muscle Relaxation Program in Covid-19 Patients After Hospital Discharge: Randomized Clinical Trial
Anticipated Study Start Date :
Dec 15, 2021
Anticipated Primary Completion Date :
Aug 15, 2022
Anticipated Study Completion Date :
Aug 15, 2022

Arms and Interventions

ArmIntervention/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

Outcome Measures

Primary Outcome Measures

  1. Functional capacity [change from baseline in 6MWT at 2 and 6 weeks]

    six minute walk test (6MWT)

Secondary Outcome Measures

  1. 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

  2. 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.

  3. 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.

Other Outcome Measures

  1. health status [change from baseline in SGRQ at 6 week]

    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.

  2. fatigue [change from baseline in FSS at 2 and 6 weeks]

    fatigue severity scale (FSS). FSS is nine item scale. the total score range is 1-7. a higher score indicates a worse fatigue severity.

  3. Quality of life and well-being [change from baseline in SF36 at 6 week]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Iran University of Medical Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Iran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT04741282
Other Study ID Numbers:
  • 18225
First Posted:
Feb 5, 2021
Last Update Posted:
Nov 16, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 16, 2021