NCT04741282

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable covid19

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 5, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2021

Completed
Last Updated

September 28, 2023

Status Verified

February 1, 2023

Enrollment Period

6 months

First QC Date

January 30, 2021

Last Update Submit

September 26, 2023

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

  • Functional capacity

    six minute walk test (6MWT)

    change from baseline in 6MWT at 2 and 6 weeks

Secondary Outcomes (3)

  • dyspnea

    change from baseline in Borg scale at 2 and 6 weeks

  • Sleep quality

    change from baseline in PSQI at 6 week

  • anxiety and depression

    change from baseline in HADS at 6 week

Other Outcomes (3)

  • health status

    change from baseline in SGRQ at 6 week

  • fatigue

    change from baseline in FSS at 2 and 6 weeks

  • Quality of life and well-being

    change from baseline in SF36 at 6 week

Study Arms (2)

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.

Other: Pulmonary telerehabilitationOther: 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.

Other: Pulmonary telerehabilitation

Interventions

Pulmonary telerehabilitationOTHER

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

pulmonary telerehabilitationpulmonary telerehabilitation plus progressive muscle relaxation training
progressive muscle relaxation trainingOTHER

summarized Jacobson progressive muscle relaxation training method

pulmonary telerehabilitation plus progressive muscle relaxation training

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Covid 19 patient that confirmed with polymerase chain reaction test (PCR)
  • Hospitalized Corvid 19 patients after discharge
  • Accessibility to internet and using video call

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Iran university of medical sciences

Tehran, Iran

Location

MeSH Terms

Conditions

COVID-19

Interventions

Autogenic Training

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

HypnosisMind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Javad Sarrafzadeh, PhD

    Department of Physiotherapy, School of Rehabilitation Sciences, Iran University of Medical Sciences

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2021

First Posted

February 5, 2021

Study Start

May 1, 2021

Primary Completion

October 30, 2021

Study Completion

October 30, 2021

Last Updated

September 28, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

IR(1)