The Effect of Walking Exercise in Patients With Chronic Obstructive Pulmonary Disease

NCT07185659 | Recruiting

• 1 other identifier: 09-XD-098
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

"Patients were divided into two groups: the experimental group (E group) and the control group (C group). The E group received standard care, walking exercise, and elastic band exercise, and wore a smart bracelet to record walking steps and sleep for three months. During the first month, participants performed walking exercise for 100 minutes per week and used a red elastic band for resistance training. In the second month, walking exercise increased to 150 minutes per week with a green elastic band. In the third month, walking exercise increased to 150-300 minutes per week with a blue elastic band. The C group wore the smart bracelet to record walking steps and sleep for three months. Each group included 34 participants. The study was conducted from September 9, 2021, to December 31, 2025. Exclusion criteria included panic disorder, cognitive impairment, current cancer treatment, angina pectoris or myocardial infarction within the past 3 months, participation in high-intensity rehabilitation exercise, and walking dysfunction. Participants were required to follow the study protocol.

• Assessments\*\*:
• Anxiety and Depression\*\*:Measured using the Chinese version of the Hospital Anxiety and Depression Scale (HADS).
• Dyspnea\*\*:Measured using the Modified Medical Research Council (mMRC) scale.
• Life and Sleep quality\*\*:Measured using the COPD Assessment Test (CAT) and Chinese Version of the Pittsburgh Sleep Quality Index (CPSQI).

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Chronic obstructive pulmonary disease

Outcome Measures

Primary Outcomes (5)

• Hospital Anxiety and Depression Scale (HADS)

  HADS was used to assess differences between groups and over time. The questionnaire consists of 14 items: 7 for anxiety and 7 for depression. Scores range from 0 to 21 for each subscale, with higher scores indicating greater levels of anxiety and depression.

  Patients were assessed before discharge as the baseline, and reassessed at 4, 8, and 12 weeks post-discharge.

• modified Medical Research Council (mMRC)

  The mMRC scale was used to assess differences in dyspnea severity between groups over time. The mMRC is a five-point scale ranging from 0 (least severe) to 4 (most severe), with higher scores indicating greater dyspnea severity.

  Patients were assessed before discharge as the baseline, and reassessed at 4, 8, and 12 weeks post-discharge.

• COPD Assessment Test (CAT)

  The COPD Assessment Test (CAT) was used to assess differences between groups over time. The CAT consists of 8 items scored from 0 to 5, yielding a total score of 0 to 40, with higher scores indicating a greater impact of COPD on quality of life.

  Patients were assessed before discharge as the baseline, and reassessed at 4, 8, and 12 weeks post-discharge.

• Chinese Version of the Pittsburgh Sleep Quality Index (CPSQI)

  CPSQI was used to assess differences between groups over time. Scores range from 0 to 21, with higher scores indicating poorer sleep quality. A score greater than 5 denotes poor sleep quality.

  Patients were assessed before discharge as the baseline, and reassessed at 4, 8, and 12 weeks post-discharge.

• Six-Minute Walk Test ( 6MWT )

  The six-minute walk test (6MWT) was used to assess differences between groups and over time. It is an important measure of patients' functional exercise capacity.

  Patients were assessed before discharge as the baseline, and reassessed at 4, 8, and 12 weeks post-discharge.

Secondary Outcomes (7)

• Daily walking activity:(1)total steps

  Patients were monitored over a 12-week period, with formal assessments conducted at 4, 8, and 12 weeks post-discharge.

• Daily walking activity:(2)total walking distance

  Patients were monitored over a 12-week period, with formal assessments conducted at 4, 8, and 12 weeks post-discharge.

• Sleep status : (1)daily total sleep duration

  Patients were monitored over a 12-week period, with formal assessments conducted at 4, 8, and 12 weeks post-discharge.

• Sleep status : (2)daily light sleep duration

  Patients were monitored over a 12-week period, with formal assessments conducted at 4, 8, and 12 weeks post-discharge.

• Sleep status : (3) Daily deep sleep duration

  Patients were monitored over a 12-week period, with formal assessments conducted at 4, 8, and 12 weeks post-discharge.

Study Arms (2)

walking exercise and resistance exercise with elastic band

EXPERIMENTAL

From weeks 1 to 12, participants' daily walking steps were monitored using a wearable device (smart bracelet). Participants performed walking exercises 5 days per week, twice daily (morning and evening sessions). In weeks 1-4, the prescribed dose was 100 minutes per week (10 minutes per session); in weeks 5-8, 150 minutes per week (15 minutes per session); and in weeks 9-12, 150 to 300 minutes per week (20 to 30 minutes per session). Leg resistance extension exercises were also performed with progressively stronger elastic bands: red (weeks 1-4), green (weeks 5-8), and blue (weeks 9-12). During weeks 1-2 and 5-6, exercises were performed 3 times per week with 2 sets per session, which increased to 3 sets per session during weeks 3-4, 7-8, and 11-12.

Device: Elastic band; Device: Xiaomi Mi Band 4 wearable device; Behavioral: Walking

routine nursing care and health education

PLACEBO COMPARATOR

Participants received routine nursing care and health education. From weeks 1 to 12, their daily walking steps were monitored using a wearable device (smart bracelet)

Device: Xiaomi Mi Band 4 wearable device

Interventions

Elastic band DEVICE

Thera-Band® elastic band exercise protocol: First stage (weeks 1-4): Participants performed leg resistance stretching exercises with a red elastic band. In weeks 1-2, exercises were performed 3 times per week, with 2 sets per session; in weeks 3-4, 3 times per week, with 3 sets per session. Second stage (weeks 5-8): Participants performed leg resistance stretching exercises with a green elastic band. In weeks 5-6, exercises were performed 3 times per week, with 2 sets per session; in weeks 7-8, 3 times per week, with 3 sets per session. Third stage (weeks 9-12): Participants performed leg resistance stretching exercises with a blue elastic band. In weeks 9-10, exercises were performed 3 times per week, with 2 sets per session; in weeks 11-12, 3 times per week, with 3 sets per session.

walking exercise and resistance exercise with elastic band

Xiaomi Mi Band 4 wearable device DEVICE

The Xiaomi Mi Band 4 wearable device has been certified by the National Communications Commission (Certification No. CCAG19LP0080T6). From weeks 1 to 12, participants' daily walking steps were monitored using the Xiaomi Mi Band 4 wearable device.

routine nursing care and health education; walking exercise and resistance exercise with elastic band

Walking BEHAVIORAL

Walking exercise plan

walking exercise and resistance exercise with elastic band

Eligibility Criteria

• Age: 40 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Inpatients diagnosed with chronic obstructive pulmonary disease (COPD) according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria.
• Age ≥ 40 years.
• Post-bronchodilator FEV₁/FVC ratio \< 70%.
• History of smoking.
• Ability to perform walking exercises.
• Willingness of the patient or a family member to provide written informed consent.

You may not qualify if:

• Panic disorder.
• Presence of delirium with inability to cooperate.
• Currently receiving cancer treatment.
• Angina pectoris or myocardial infarction within the past 3 months.
• Currently undergoing high-intensity rehabilitation exercises.

Sponsors & Collaborators

• Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation: lead

Study Sites (1)

Taipei Tzu Chi Hospital

New Taipei City, Xindian Dist., 23142, Taiwan

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Walking

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise; Motor Activity

Study Officials

• Pei-Ching Hung, Hand nurse

  Taipei Tzuchi hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pei-Ching Hung, Head nurse

CONTACT

+886-2-66289779; linda8123@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: HEAD NURSE

Model Details: Patients were randomly assigned to either the experimental group (E group) or the control group (C group). The experimental group received standard care, walking exercise, and elastic band exercise, and wore a smart bracelet to record walking steps and sleep for three months. During the first month, participants performed walking exercise for 100 minutes per week and used a red elastic band for resistance training. In the second month, walking exercise increased to 150 minutes per week with a green elastic band. In the third month, walking exercise increased to 150-300 minutes per week with a blue elastic band. The control group wore a smart bracelet to record walking steps and sleep for three months but did not participate in the structured exercise program

Study Record Dates

• First Submitted: February 19, 2023
• First Posted: September 22, 2025
• Study Start: September 9, 2021
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)