NCT04791072

Brief Summary

Respiratory exercise training and aerobic exercise training will be given to patients who have been hospitalized in intensive care due to COVID 19 and underwent IMV, who were hospitalized in the service and underwent NIMV or high-flow oxygen inhalation, and whose respiratory symptoms persist after discharge. The patients in the study group will be called by phone once a week and a motivating conversation will be made. No control will be made to the control group. Before and after the training, 6-minute walking test, MRC dyspnea scale, SGRQ quality of life questionnaire and hospital anxiety depression scale will be applied.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at below P25 for not_applicable covid19

Timeline
Completed

Started Mar 2021

Status
unknown

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

February 27, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 10, 2021

Completed
Last Updated

March 10, 2021

Status Verified

March 1, 2021

Enrollment Period

Same day

First QC Date

February 27, 2021

Last Update Submit

March 9, 2021

Conditions

Covid19Rehabilitation

Keywords

covid19rehabilitationtelecoaching

Outcome Measures

Primary Outcomes (1)

  • Exercise Capacity

    Six Minute- walk test

    Change from baseline six minute walk distance at 8 week

Secondary Outcomes (3)

  • Dyspnea Assessment

    Change from baseline dyspnea at 8 week

  • Quality of Life Assessment

    Change from baseline quality of life at 8 week

  • Anxiety and Depression

    Change from baseline anxiety and depression at 8 week

Study Arms (2)

Telecoaching group

EXPERIMENTAL

They will be given breathing exercise training and will be asked to do it every day for 8 weeks. In addition to breathing exercises, the use of incentive spirometry and aerobic exercise training will be provided. They will be asked to do breathing exercises, use of incentive spirometry and strengthening exercises for at least 20 minutes every day and 5 times a week. They will be called by phone once a week and encouraging speeches will be made.

Other: Exercise

Control Group

ACTIVE COMPARATOR

They will be given breathing exercise training and will be asked to do it every day. In addition to breathing exercises, the use of incentive spirometry and aerobic exercise training will be provided. They will be asked to do breathing exercises, use of incentive spirometry and strengthening exercises for at least 20 minutes every day and 5 times a week. There will be no interviews in the control group.

Other: Exercise

Interventions

ExerciseOTHER

Breathing exercise training Use of incentive spirometry Aerobic exercise training Strengthening exercises

Control GroupTelecoaching group

Eligibility Criteria

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

You may qualify if:

  • Being treated in intensive care unit due to COVID-19 pneumonia,
  • Receiving IMV, NIMV, or high-flow oxygen therapy
  • Patients whose respiratory symptoms persist despite discharge

You may not qualify if:

  • Patients with PCR test +
  • Patients without any complaints.
  • Patients who are hospitalized and discharged within 10 days
  • Patients with orthopedic, neurological, cognitive problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Sahin H, Naz I, Karadeniz G, Sunecli O, Polat G, Ediboglu O. Effects of a home-based pulmonary rehabilitation program with and without telecoaching on health-related outcomes in COVID-19 survivors: a randomized controlled clinical study. J Bras Pneumol. 2023 Jan 23;49(1):e20220107. doi: 10.36416/1806-3756/e20220107. eCollection 2023.

    PMID: 36700571DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

February 27, 2021

First Posted

March 10, 2021

Study Start

March 1, 2021

Primary Completion

March 1, 2021

Study Completion

March 1, 2021

Last Updated

March 10, 2021

Record last verified: 2021-03