NCT05760352

Brief Summary

The present study aims to investigate the effect of different exercise training in patients with chronic respiratory disease.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 27, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 8, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

April 14, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 29, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 29, 2024

Completed
Last Updated

March 12, 2024

Status Verified

March 1, 2024

Enrollment Period

11 months

First QC Date

February 27, 2023

Last Update Submit

March 9, 2024

Conditions

Chronic Pulmonary Disease

Keywords

Pulmonary rehabilitationEccentric cycling exerciseHelmet ventilationChronic respiratory disease

Outcome Measures

Primary Outcomes (1)

  • Peak % of oxygen consumption

    To observe the maximum exercise performance

    9 weeks

Secondary Outcomes (5)

  • Heart rate, b/m

    9 weeks

  • Respiratory rate, b/m

    9 weeks

  • Mean arterial blood pressure, mmHg

    9 weeks

  • FEV1/FVC, %

    9 weeks

  • Saturation of Peripheral Oxygen(SpO2), %

    9 weeks

Study Arms (3)

Control group

NO INTERVENTION

Self-paced exercise

Intervention Group: eccentric cycling exercise

EXPERIMENTAL

Received eccentric cycling exercise

Device: Eccentric bike

Intervention Group: eccentric cycling exercise with helmet ventilation

EXPERIMENTAL

Eccentric cycling exercise combined with helmet ventilation

Device: Eccentric bikeDevice: Helmet ventilation

Interventions

Eccentric bikeDEVICE

Received eccentric cycling exercise

Intervention Group: eccentric cycling exerciseIntervention Group: eccentric cycling exercise with helmet ventilation
Helmet ventilationDEVICE

Using helmet ventilation during eccentric cycling exercise

Intervention Group: eccentric cycling exercise with helmet ventilation

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 20 and 80 years
  • Diagnosed with chronic respiratory diseases
  • Having undergone pulmonary rehabilitation for more than 3 months

You may not qualify if:

  • Existing of tracheostomy
  • Those who use oxygen therapy or ventilator at home
  • Severe left heart failure (NYHA III-IV)
  • Neuromuscular disease
  • Acute exacerbation within the past three months
  • Those who are unable to cooperate with the cardiopulmonary exercise test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fu Jen Catholic University Hospital, Fu Jen Catholic University

New Taipei City, 24352, Taiwan

Location

Study Officials

  • Ke-Yun Chao, PhD

    Fu Jen Catholic University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Group leader of Respiratory Therapists

Study Record Dates

First Submitted

February 27, 2023

First Posted

March 8, 2023

Study Start

April 14, 2023

Primary Completion

February 29, 2024

Study Completion

February 29, 2024

Last Updated

March 12, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)