Pedometer Assisted Physical Activity in Individuals With COPD. A Multicenter Randomized Controlled Trial.

NCT05098964 | Completed

• 1 other identifier: 713/IX/HREC/2018
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

Home based and tele-rehabilitation programs may be potentially useful to deliver and to maintain the benefits in difficult-to-reach areas. Tele-health technologies allow for distribution of healthcare services and exchange of information between healthcare providers and patients in different geographical locations and provide an important tool to reach people living in rural communities. In a previous single center study, we had shown that a home pedometer assisted program to enhance physical activity was as effective as and cheaper than a standard outpatient supervised exercise training program.13 We wondered whether the results of that study 13 might be confirmed in a larger multicenter randomized controlled trial (RCT). Therefore the aim of this multicenter RCT was to evaluate the benefits and costs of a program of pedometer assisted physical activity as compared to standard hospital outpatient supervised exercise training program.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Pulmonary rehabilitation; Tele-medicine; Exercise capacity; Dyspnoea; Quality of life

Outcome Measures

Primary Outcomes (1)

• Exercise Tolerance

  Exercise tolerance was assessed by mean of the 6MWT according to accepted

  Before and after program (6 weeks)

Secondary Outcomes (1)

• Physical Activity

  Before and after program (6 weeks)

Study Arms (2)

Study Group (pedometer)

EXPERIMENTAL

Participants received an Omron HJ 321 pedometer (Omron Healthcare Co Ltd, Kyoto, Japan) and were asked to walk at home at the fastest step pace as possible, for at least 30 minutes every day, up to 6 weeks.

Device: pedometer home based rehabilitation

Control Group

EXPERIMENTAL

participants received supervised exercise training at outpatient clinics for total 18 sessions (3 weekly sessions for 6 weeks).

Other: Exercise training

Interventions

pedometer home based rehabilitation DEVICE

Home based pulmonary rehabilitation for 6 weeks using pedometer Omron HJ 321 pedometer (Omron Healthcare Co Ltd, Kyoto, Japan)

Also known as: pedometer

Study Group (pedometer)

Exercise training OTHER

Hospital based exercise training for 6 weeks

Control Group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals with COPD as defined by the Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD) guidelines,2 40-80 years old, were recruited from the outpatient clinics of Moewardi and Mohammad Rabain hospitals.
• All subjects had to be in stable conditions as assessed by absence of worsening in symptoms, i.e. no change in cough, and/or sputum beyond day-to-day variability which would have been sufficient to warrant a change in the management prescribed at discharge from hospitals or prescribed at home by their GP, and stability in blood gas values (e.g. no respiratory acidosis).

You may not qualify if:

• Individuals refusing to participate, participated in a pulmonary rehabilitation program during the previous 6 months, or with active malignancy, previous lung surgery, unstable cardiovascular diseases, orthopaedic and/or neuromuscular diseases interfering with their ability to walk, or inability to connect with internet and operate WhatsApp video call applications were excluded.

Sponsors & Collaborators

• Yusup subagio sutanto: lead

Study Sites (1)

Pulmonary department of medical faculty Universitas Sebelas Maret

Surakarta, Central Java, 57126, Indonesia

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Dyspnea

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief of pulmonary department

Study Record Dates

• First Submitted: October 17, 2021
• First Posted: October 29, 2021
• Study Start: February 1, 2019
• Primary Completion: February 29, 2020
• Study Completion: December 31, 2020
• Last Updated: October 29, 2021

Record last verified: 2021-10

Locations

ID (1)