Clinical Study on Improving Exercise Capacity in Chronic Obstructive Pulmonary Disease Through Smart IoT-Remote Home Breathing Guidance

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-80
SponsorHenan University of Traditional Chinese Medicine

About this trial

This study aims to evaluate the clinical efficacy of breath-guided improvement of COPD exercise ability, establish a breath-guided rehabilitation program of intelligent iot and remote home, improve COPD exercise ability, reduce acute exacerbation, and form high-quality clinical evidence.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with COPD in stable stage

Patients with grade 2 to 4 lung function

Age 40~80 years old

Be able to use smart phones, computers and other devices independently or with the help of family members during home training

Disqualifiers

Pregnant or lactating women and patients with recent pregnancy plans

Delirious, dementia, all kinds of mental illness

Tumor patients who have undergone resection, radiation, and chemotherapy within 5 years

Patients with severe osteoarthropathy or osteoporosis, unstable fractures

Trial design

Design model

Parallel

Treatments tested in this trial

  • Breathing guided exercise

    Behavioral

    Breathing guided exercise are divided into six sections: relaxing standing, two fields breathing, regulating lung and kidney, turning side finger, running kidney hall and nourishing qi and collecting gong. Exercise time: 5 days a week, 1 to 2 times a day, a total of 24 weeks.

  • Flat walking training

    Behavioral

    Flat walking training can be performed either outdoors or on flat indoor surfaces at a steady pace of 80 to 120 steps per minute for at least 30 minutes each session, raising the heart rate to the target range and maintaining it for over 10 minutes. This should be done 3 to 5 times a week, with 1 to 2 sessions each day, for a total of 24 weeks. The intensity of the exercise is moderate. The target heart rate based on heart rate reserve is calculated as (maximum heart rate during exercise - resting heart rate) × (40-60)% + resting heart rate.

Treatment groups

548 Participants
are divided into 2 treatment groups
Group A: Breathing guided rehabilitation groupExperimental treatment 1 intervention
Group B: Flat ground walking trainingActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

6 Minutes Walking Distance Test (6MWD)

The 6-minute walking distance of the two groups was calculated

Time frame
Changes in baseline 6MWD test at weeks 12 and 24 of the treatment period and at 28 weeks of follow-up.

Secondary outcomes

1

Incidence of acute exacerbation

The proportion of patients with ≥1 acute exacerbation in each group during the study period was recorded. If the interval between two acute exacerbations was within 5 days, it was considered as 1 acute exacerbation.

Time frame
Changes in baseline Incidence of acute exacerbation at weeks 12 and 24 of the treatment period and at 28 weeks of follow-up.
2

Degree of breathing difficulty

The modified Medical Research Council dyspnoea scale (mMRC) will be used to assess severity of dyspnea. The mMRC scale is a 4-point (0-4) scale. "0" means no dyspnea perception, "4" means severe dyspnea perception.

Time frame
Changes in baseline mMRC scores at weeks 12 and 24 of the treatment period and at 28 weeks of follow-up.
3

Borg dyspnea score

Borg dyspnea score is a 10-point (0-10) scale based on the severity of dyspnoea. "0" means no dyspnea perception, "10" means most severe dyspnea perception.

Time frame
Changes in baseline Borg dyspnea score at weeks 12 and 24 of the treatment period and at 28 weeks of follow-up.
4

The COPD Assessment Test(CAT)

The COPD Assessment Test (CAT) is an 8-item questionnaire that assesses health status in patients with COPD. The questionnaire uses a 0-5 point scale, with higher values indicating a greater impact of COPD on the patient.

Time frame
Changes in baseline CAT scores at weeks 12 and 24 of the treatment period and at 28 weeks of follow-up.

Other outcomes

Sponsors and contacts

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Henan University of Traditional Chinese Medicine

Lead sponsor

Shanxi Bethune Hospital

Collaborator

Henan Fantasy Intelligent Technology Co., Ltd

Collaborator

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