Clinical Effects of Internet Assisted Pulmonary Rehabilitation of COVID-2019 Pneumonia Patients After Discharge

• ClinicalTrials.gov Identifier: NCT04368793
• Recruitment Status: Recruiting
• First Posted: April 30, 2020
• Last Update Posted: July 17, 2020
• Sponsor: China-Japan Friendship Hospital
• Collaborators: Wuhan lung Hospital; Wuhan central hospital; Wuhan University; Ai You Foundation
• Information provided by (Responsible Party): Hongtao Niu, China-Japan Friendship Hospital

Tracking Information

• First Submitted Date: April 23, 2020
• First Posted Date: April 30, 2020
• Last Update Posted Date: July 17, 2020
• Actual Study Start Date: April 6, 2020
• Estimated Primary Completion Date: December 31, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 8, 2020)

• Six-minute walking distance (6MWD) [ Time Frame: One year ]
  Walking distance within six minutes
• Pulmonary function [ Time Frame: One year ]
  Forced expiratory volume in one second (FEV1), forced vital capacity (FVC), etc.

Original Primary Outcome Measures (submitted: April 29, 2020)

• Pulmonary function [ Time Frame: Change from Baseline Pulmonary function at 5months ]
  Forced expiratory volume in one second, Forced vital capacity , et al.
• Respiratory muscle strength [ Time Frame: Change from Baseline Respiratory muscle strength at 5months ]
  maximal inspiratory pressure and maximal expiratory pressure
• Physical fitness assessment [ Time Frame: Change from Baseline 2-minute walking test result at 5months ]
  2-minute walking test
• Physical fitness assessment [ Time Frame: Change from Baseline short physical performance battery result at 5months ]
  short physical performance battery(SPPB)
• Physical fitness assessment [ Time Frame: Change from Baseline grip strength of both upper limbs at 5months ]
  grip strength of both upper limbs
• Physical fitness assessment [ Time Frame: Change from Baseline knee extension strength of both lower limbs at 5months ]
  knee extension strength of both lower limbs

Current Secondary Outcome Measures (submitted: July 8, 2020)

• Respiratory muscle strength [ Time Frame: One year ]
  Maximal inspiratory pressure, maximal expiratory pressure, etc.
• Physical fitness assessment [ Time Frame: One year ]
  Two-minute walking test, short physical performance battery, grip strength of both upper limbs, knee extension strength of both lower limbs, etc.
• Symptom [ Time Frame: One year ]
  Modified British Medical Research Council (mMRC) dyspnea scale, etc.
• Psychological evaluation [ Time Frame: One year ]
  Self-training depression scale (SDS) and self-rating anxiety scale (SAS)
• Quality of life [ Time Frame: One year ]
  36-item short-form health survey (SF-36), etc.
• Physical activity [ Time Frame: One year ]
  International physical activity questionnaire (IPAQ)
• Proportion of returning to society [ Time Frame: One year ]
  Proportions of returning to routine work and normal life

Original Secondary Outcome Measures (submitted: April 29, 2020)

• Symptom [ Time Frame: Change from Baseline score at 5months ]
  Modified British Medical Research council dyspnea scale, 0-4 scores, higher scores mean a worse outcome
• Psychological evaluation [ Time Frame: Change from Baseline score at 5months ]
  Self-rating depression scale, cut-off value is 53 scores, higher scores mean a worse outcome
• Psychological evaluation [ Time Frame: Change from Baseline score at 5months ]
  Self-Rating Anxiety Scale, cut-off value is 50 scores, higher scores mean a worse outcome
• Quality of life assessment scale [ Time Frame: Change from Baseline score at 5months ]
  The Medical Outcomes Study 36-Item Short-Form Health Survey. The scale reflects the quality of life from 8 aspects.It needs to be calculated by formula based on the participant's situation. The higher scores mean a better outcome.
• Physical activity level [ Time Frame: Change from Baseline score at 5months ]
  International physical activity questionnaire.It needs to be calculated by formula based on the participant's situation. The higher scores mean a better outcome.
• Proportion of returning to society [ Time Frame: Change from Baseline proportion at 5months ]
  proportion of returning to work

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Clinical Effects of Internet Assisted Pulmonary Rehabilitation of COVID-2019 Pneumonia Patients After Discharge
• Official Title: Intelligence-based Remote Pulmonary Rehabilitation and Efficacy Among Discharged COVID-19 Patients
• Brief Summary: The noval coronavirus disease 2019 (COVID-19) would cause physical and psychological dysfunctions in infected patients. We expect that an intelligence-based remote pulmonary rehabilitation scheme could improve patients' health status after hospital discharge. The intelligence-based remote pulmonary rehabilitation program is designed in a real-world and prospective manner, aiming to evaluate the efficacy of rehabilitation among 200 patients in the epicenter of China (Wuhan City) according to their varied adherence. An eight-week rehabilitation scheme, including two weeks for physicians and physiotherapists remotely guided training, and six weeks for patient self-management, will be addressed. The primary outcome of current study is six-minute walking distance and lung function, and secondly respiratory muscle strength, physical fitness assessment, symptoms and quality of life, etc. will also be assessed. Recruited patients will be followed up at week 2, 4, 8 after enrollment and at month 1, 3, 6, 12 after the rehabilitation training completed, respectively. The study has been approved by the ethics committee of China-Japan Friendship Hospital and three participating centers in Wuhan City.
• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: All discharged COVID-19 pneumonia patients who have signed the informed consent and met above eligibility criteria will be enrolled in this study.

Condition

• COVID-2019 Pneumonia
• Pulmonary Rehabilitation

Intervention

Behavioral: Remote pulmonary rehabilitation

The pulmonary rehabilitation intervention includes respiratory exercise, barehanded aerobic training, exercise prescription of elastic band impedance training, respiratory muscle strength training, etc.

Study Groups/Cohorts

Discharged COVID-19 patient cohort

All enrolled participants will be given 8 weeks (online 2 weeks + offline 6 weeks) pulmonary rehabilitation intervention, and will be followed up for at least one year, to assess their adherence and efficacy of the rehabilitation program.

Intervention: Behavioral: Remote pulmonary rehabilitation

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: July 8, 2020): 200
• Original Estimated Enrollment (submitted: April 29, 2020): 300
• Estimated Study Completion Date: December 31, 2021
• Estimated Primary Completion Date: December 31, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion criteria:

• patients diagnosed as COVID-19 pneumonia according to the Chinese diagnostic criteria (Trial 7th Edition), aged 20 years or above;
• patients who did not participate in any other rehabilitation training scheme;
• patients who did not participate in any other intervention clinical trials;
• patients who signed the informed consent and were able to adhere to a long-term follow-up for at least one year.

Exclusion criteria:

• pregnant women;
• patients with previous mental disorders or undergoing mental health treatment;
• patients with previous personality disorder, intelligence disorder, brain injury or brain disease;
• patients with serious cardiovascular, cerebrovascular, neuromuscular and other systemic diseases or other diseases affecting physical activity;
• patients with tumors and underwent treatment.

One will be considered as withdrawal if consent is revoked, lost to follow-up, or unable to take the pulmonary rehabilitation scheme due to severe exacerbation, comorbidities, injury or trauma, etc.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years to 85 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Geyi Wen, Resident; +86 13263370980; williamwgy@163.com

Contact: Lulu Yang, Resident; +86 18810904716; 1277403977@qq.com

• Listed Location Countries: China

Administrative Information

• NCT Number: NCT04368793
• Other Study ID Numbers: 2020-22-K17
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Hongtao Niu, China-Japan Friendship Hospital
• Study Sponsor: China-Japan Friendship Hospital

Collaborators

• Wuhan lung Hospital
• Wuhan central hospital
• Wuhan University
• Ai You Foundation

Investigators

• Principal Investigator: Ting Yang, Prof.; China-Japan Friendship Hospital

• PRS Account: China-Japan Friendship Hospital
• Verification Date: July 2020