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NCT Number: NCT04741282

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

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

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Iran university of medical sciences

Tehran, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pulmonary telerehabilitation

Other

pulmonary telerehabilitation program include breathing exercise,aerobics exercise and upper and lower limbs muscle strengthening exercise

progressive muscle relaxation training

Other

summarized Jacobson progressive muscle relaxation training method

Primary outcomes

  1. Functional capacity

    Time frame: change from baseline in 6MWT at 2 and 6 weeks

    six minute walk test (6MWT)

Secondary outcomes

  1. dyspnea

    Time frame: 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

    Time frame: 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

    Time frame: 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 outcomes

  1. health status

    Time frame: 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

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Iran University of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 5, 2021
Registry last updated
Sep 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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