Cardiorespiratory Exercise & Chinese Medicine for Rehabilitation of Discharged Coronavirus Disease (COVID-19) Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

172 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2023-06-30

Brief Summary

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Rehabilitation interventions can help to address the consequences of COVID-19, which include medical, physical, cognitive, and psychological related problems. The specific aims of this project are to investigate the effects of a 12-week exercise program on pulmonary fibrosis in recovering COVID-19 patients. A further aim will be to examine how Chinese herbal medicines, gut microbiome, and metabolites regulate immune function and possibly autoimmune deficiency in the rehabilitation process.

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Detailed Description

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The study will develop a new paradigm for patient rehabilitation needed now and in the future. The specific aims of this project are to investigate the effects of a 12-week program with cardiorespiratory exercise and Chinese herbal medicine on recovering COVID-19 patients and to collect qualitative and quantitative data to examine loneliness, anxiety, depression, quality of life, and mental health. A further aim will be to examine how Chinese herbal medicines, gut microbiome, and the metabolites regulate immune function, intestinal permeability, and possibly autoimmune deficiency (AID) in the pathological recovery/rehabilitation process.

In this multicenter, triple-blinded, randomized, parallel groups, controlled clinical trial, the investigator will recruit adult patients with COVID-19 and have been discharged from the hospital in Hong Kong and the Chinese Mainland.

A total of 172 eligible patients will be randomized 1:1:1:1 into four groups: cardiorespiratory exercise plus Chinese herbal medicines group, cardiorespiratory exercise group, Chinese herbal medicines group, and waiting list group for 12-week (3 months) with 12-week follow-up period.

A 4-week pilot study will be conducted to test patient recruitment and maintenance, data collection, instrumentation, and observing the adaptability and practicality of the intervention. Amendments will be made if necessary.

Conditions

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Coronavirus Disease (COVID-19)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A triple-blinded, randomized, parallel groups, controlled clinical trial. A total of 172 eligible patients will be randomized 1:1:1:1 into four groups: cardiorespiratory exercise plus Chinese herbal medicines group, cardiorespiratory exercise group, Chinese herbal medicines group and waiting list group for 12-week (3 months) with 12-week follow-up period.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Both patients and investigators will be blinded to the assigned groups. Patients will be allocated at a ratio of 1:1:1:1, the randomization will be carried out by Statistical Analysis System 9.3 (SAS 9.3) statistical software. (Descript how the blinding works here) One copy of the blind codes will be held by the project responsible unit. The statistician will be blinded throughout the study.

Study Groups

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Cardiorespiratory Exercise plus Chinese Herbal Medicines Group

Includes:

1.12-week progressive \& individualized exercise, 60mins/session, 3 sessions/week, total 36 exercise sessions. Components: a set of home-based tele-exercise sessions with remote monitoring of vital signs; individualized action plan to perform various daily physical activities; educational sessions on self-management \& habit formation; access to a call center; \& counselling sessions to enhance motivation to regularly engage in daily physical activities.

2.Chinese herbal formula of Modified Bai He Gu Jin Tang prescribed in granules, 10g/day (5g dissolved in 200ml of hot water, b.i.d), twice/day after breakfast \& dinner, 7days/week for 12 weeks.

Group Type EXPERIMENTAL

Cardiorespiratory Exercise

Intervention Type OTHER

Each exercise session (40-60 minutes) will include warm-up, aerobic training, resistance training, cool-down, as well as inspiratory muscle training

Modified Bai He Gu Jin Tang

Intervention Type OTHER

The Chinese herbal formula of Modified Bai He Gu Jin Tang will be prescribed in granules. A dose of 10g a day (5g, b.i.d) will be ingested. Patients will dissolve a sachet of granules (5.0g) in 200ml of hot water, twice a day after breakfast and dinner, seven days a week for three months.

Cardiorespiratory Exercise Group

Includes:

A 12-week progressive \& individualized exercise, 60mins/session, 3 sessions/week, total 36 exercise sessions. Components: a set of home-based tele-exercise sessions with remote monitoring of vital signs; individualized action plan to perform various daily physical activities; educational sessions on self-management \& habit formation; access to a call center; \& counselling sessions to enhance motivation to regularly engage in daily physical activities.

Group Type EXPERIMENTAL

Cardiorespiratory Exercise

Intervention Type OTHER

Each exercise session (40-60 minutes) will include warm-up, aerobic training, resistance training, cool-down, as well as inspiratory muscle training

Chinese Herbal Medicines Group

Includes:

Chinese herbal formula of Modified Bai He Gu Jin Tang prescribed in granules, 10g/day (5g dissolved in 200ml of hot water, b.i.d), twice/day after breakfast \& dinner, 7days/week for 12 weeks.

Group Type EXPERIMENTAL

Modified Bai He Gu Jin Tang

Intervention Type OTHER

The Chinese herbal formula of Modified Bai He Gu Jin Tang will be prescribed in granules. A dose of 10g a day (5g, b.i.d) will be ingested. Patients will dissolve a sachet of granules (5.0g) in 200ml of hot water, twice a day after breakfast and dinner, seven days a week for three months.

Waiting List Group

The waiting list control sign will be adopted to conceal allocation results from the patients and further to reduce selection and confounding bias and increase their adherence to the study. Patients in the waiting list control group will receive no treatment in the study period (including a 12-week intervention period and a 12-week follow-up period). However, they will receive Chinese herbal medicines after the completion of the study (i.e., after the 3rd wave of measurements in the 25th weeks).

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Cardiorespiratory Exercise

Each exercise session (40-60 minutes) will include warm-up, aerobic training, resistance training, cool-down, as well as inspiratory muscle training

Intervention Type OTHER

Modified Bai He Gu Jin Tang

The Chinese herbal formula of Modified Bai He Gu Jin Tang will be prescribed in granules. A dose of 10g a day (5g, b.i.d) will be ingested. Patients will dissolve a sachet of granules (5.0g) in 200ml of hot water, twice a day after breakfast and dinner, seven days a week for three months.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. aged 18 years and above;
2. a percentage of predicted forced vital capacity (FVC) \<90%, and/or a percentage of predicted carbon monoxide diffusing capacity \< 90% (King 2014);
3. able to communicate in Cantonese.

Exclusion Criteria

1. having acute exacerbations in the 12-week preceding recruitment patients;
2. having any contraindications for exercise (e.g., physical disability, uncontrolled mental disorders, unstable heart disease, unable to perform muscle strength tests)
3. Female - Pregnant or plan to become pregnant in the next 1 year
4. Unable to communicate in Cantonese or Mandarin
5. Currently participating in other similar rehabilitation programs or research

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No