NCT05427773

Brief Summary

The primary objective is to assess the relation between involuntary and voluntary assessed quadriceps muscle endurance in patients with COPD. We hypothesized a good correlation (\>0.8) between the measurements.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2022

Shorter than P25 for all trials

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

June 13, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 22, 2022

Completed
13 days until next milestone

Study Start

First participant enrolled

July 5, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2023

Completed
Last Updated

February 3, 2023

Status Verified

May 1, 2022

Enrollment Period

7 months

First QC Date

June 13, 2022

Last Update Submit

February 2, 2023

Conditions

Keywords

Peripheral muscle enduranceElectrical stimulation

Outcome Measures

Primary Outcomes (3)

  • Electrically evoked fatigue resistance (%)

    Fatigue resistance (%) is the decline in muscle force generated using electrical stimulation.

    Performed in first week of pulmonary rehabilitation program

  • Voluntary isometric quadriceps endurance (time to fatigue).

    Voluntary isometric quadriceps endurance (time to fatigue in seconds) is determined on the computerized dynamometer. The isometric endurance test protocol is performed by asking participants to maintain, for as long as possible, an isometric quadriceps contraction representing 60% of the individual isometric maximal voluntary contraction (MVC) force. The test will be ended if the force of the contraction was less than 50% of the MVC for three consecutive seconds.

    Performed in first week of pulmonary rehabilitation program

  • Voluntary isokinetic work fatigue index.

    Voluntary isokinetic work fatigue (%) is the decline in work over 30 repetitions determined on the computerized dynamometer. The isokinetic protocol consists of 30 contractions at an angular velocity of 90°/s with maximal effort during extension and passive (submaximal) flexion. Work fatigue index = \*work first 5 repetitions - work last 5 repetitions) / work first 5 repetitions \* 100%

    Performed in first week of pulmonary rehabilitation program

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with COPD that start with the pulmonary rehabilitation program at the Radboudumc in Nijmegen.

You may qualify if:

  • COPD, based on GOLD classification
  • Clinically stable according to the pulmonary physician, i.e. no exacerbation and/or hospitalization within the previous 4 weeks
  • Age between 40-80 years
  • Take part in the pulmonary rehabilitation program at Radboudumc (Nijmegen)

You may not qualify if:

  • Inability to understand the Dutch language
  • Musculoskeletal and neurological problems influencing quadriceps muscle function testing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboudumc

Nijmegen, Gelderland, 6525 GA, Netherlands

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2022

First Posted

June 22, 2022

Study Start

July 5, 2022

Primary Completion

January 20, 2023

Study Completion

January 20, 2023

Last Updated

February 3, 2023

Record last verified: 2022-05

Locations