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Status unknownNCT03250000COPD-EXUpdated Sep 8, 2017

Changes in Microcirculation and Functional Status During Exacerbation of COPD

An observational study in COPD Exacerbation, Physical Activity and Retinal Vascular, sponsored by Hasselt University. Status unknown at 1 site in Belgium. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2017-09-08.

Sponsored by Hasselt University · Observational

The sponsor has not verified this record recently (last verified Sep 2017), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
40 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 13 studies in Motor Activity by Hasselt University — 4 open to participants now, 6 under way, none of them phase 3. Motor Activity · Hasselt University.

Started
2017
the only one that year
Observational
5 of 13
1 open now
Registered
2nd of 13
by date

Among the 13 studies in Motor Activity by Hasselt University, this one is the only one that started in 2017, is one of 5 observational ones, and was the 2nd registered.

Motor Activity

9,798 studies on the registry are indexed under Motor Activity; 1,910 are open to participants now.

Browse Motor Activity studies →

Open to participants now

4 of the 13 studies in Motor Activity by Hasselt University are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 4 open studies →

Where they have run

Who these studies take

Of the 1,201 Motor Activity studies recruiting now, 517 (43%) set no upper age limit and 535 (45%) stop at 75 or younger; 180 take children under 18; 420 take healthy volunteers.

This study: 40 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

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02

Study summary

This study investigates the influence of acute exacerbation of chronic obstructive pulmonary disease (COPD) on retinal microcirculation, on functional status and also investigates the prognostic value of retinal vessel caliber assessment in terms of hospitalization and mortality during 2 years of follow-up.

Read the detailed description

Recent findings suggest that patients with chronic obstructive pulmonary disease (COPD) are at increased risk for myocardial infarction and stroke during periods of acute exacerbation. These findings might be related to acute endothelial changes associated to increased systemic inflammation. Changes in the microcirculation can be explored noninvasively by studying retinal blood vessels that are visualized in fundus images. The retinal blood vessels have anatomical and physiological features that are comparable with the coronary circulation.

Patients with COPD experience quadriceps muscle weakness, which worsens during hospitalization by \~1% per day. This is the result of physical inactivity, in combination with increased oxidative stress and systemic inflammation. Physical inactivity is induced by the hospital environment, but is also related to symptoms of dyspnea caused by increased work of breathing and oxygen desaturation.

Muscle weakness and physical inactivity are associated to poor functional status and recurrent hospital admissions, independent of pulmonary impairment, which makes those patients with frequent exacerbations prone to enter a vicious cycle.

Simple functional screening tests during hospital stay might enable us to quantify the impact of a hospitalization on functional status and to identify patients at risk for repeated exacerbations.

03

Conditions studied

  • COPD Exacerbation
  • Physical Activity
  • Retinal Vascular

Browse trials for

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Stable and exacerbated COPD patients

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Stable (post-bronchodilator forced expiratory volume / forced vital capacity \< 0.7), no exacerbations in the previous weeks. COPD patients with diagnosis of acute exacerbation, based on the GOLD criteria.

Exclusion criteria

Exclusion Criteria:

  • Inability to walk without support from others
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • COPD-stable

    Stable COPD patients at pulmonology consultation in Ziekenhuis Oost-Limburg (ZOL) Genk

  • COPD-Ex

    Patients admitted to the respiratory ward of ZOL Genk with a diagnosis of acute exacerbation, based on the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria.

06

What researchers measure

Primary outcomes

  1. Changes in Retinal microcirculation

    Fundus of the right eye will be photographed using a retinal camera. The vessel diameters had geometric patterns will be measure.

    Time frame: Stable: Outpatient clinic/ COPD exacerbated: Day 2-3 in hospital; Day 5-7 in hospital; 4 weeks after discharge

  2. Changes in Functional status tests

    Short physical performance battery (SPPB), which consists of a four meter gait test, a five-repetition sit-to-stand test and a balance test will be done. All the testes ranged from 0 to 4 and the sum of the three components comprised the final SPPB score, with a possible range from 0 to 12.

    Time frame: Stable: Outpatient clinic/ COPD exacerbated: Day 2-3 in hospital; Day 5-7 in hospital; 4 weeks after discharge

Secondary outcomes

  1. Functional exercise tolerance

    Six minute walk test will be done

    Time frame: Stable: Outpatient clinic/ COPD exacerbated: Day 2-3 in hospital; Day 5-7 in hospital; 4 weeks after discharge

  2. Muscle Function

    Handgrip and Isometric-eccentric quadriceps strength test will be done

    Time frame: Stable: Outpatient clinic/ COPD exacerbated: Day 2-3 in hospital; Day 5-7 in hospital; 4 weeks after discharge

  3. Changes in Daily physical activity

    Activity level will be assess by an accelerometer, the patient will be worn for 7 days.

    Time frame: Stable: Outpatient clinic/ COPD exacerbated: Day 2-3 in hospital; Day 5-7 in hospital; 4 weeks after discharge

  4. Impact of the disease

    The COPD assessment test will be applied

    Time frame: Stable: Outpatient clinic/ COPD exacerbated: Day 2-3 in hospital; Day 5-7 in hospital; 4 weeks after discharge

  5. Impact of the dyspnea

    The modified medical research council scale will be applied

    Time frame: Stable: Outpatient clinic/ COPD exacerbated: Day 2-3 in hospital; Day 5-7 in hospital; 4 weeks after discharge

  6. Impact of the depression

    The patient health questionnaire will be applied

    Time frame: Stable: Outpatient clinic/ COPD exacerbated: Day 2-3 in hospital; Day 5-7 in hospital; 4 weeks after discharge

  7. Impact of the fatigue

    The checklist individual strength- fatigue sub-scale will be applied

    Time frame: Stable: Outpatient clinic/ COPD exacerbated: Day 2-3 in hospital; Day 5-7 in hospital; 4 weeks after discharge

  8. Body composition

    Bio-electrical impedance analysis will be used to estimate fat-free body mass based on the assessment of total body water. Body mass index and waist circumference will provide general information about body composition.

    Time frame: Stable: Outpatient clinic/ COPD exacerbated: Day 2-3 in hospital; Day 5-7 in hospital; 4 weeks after discharge

  9. Cardiovascular parameters

    Resting ankle and brachial blood pressure will be measured and the ankle brachial pressure index will be calculated by the ratio of ankle to ipsilateral brachial systolic blood pressure

    Time frame: Stable: Outpatient clinic/ COPD exacerbated: Day 2-3 in hospital; Day 5-7 in hospital; 4 weeks after discharge

  10. Continuous assessment of oxygen saturation

    A portable pulse oximeter will be worn to asses transcutaneous oxygen saturation for 24 hours in patients with an exacerbation.

    Time frame: COPD exacerbated: Day 5-7 in hospital; 4 weeks after discharge

  11. Continuous assessment of heart rate

    A portable pulse oximeter will be worn to asses heart rate for 24 hours in patients with an exacerbation.

    Time frame: COPD exacerbated: Day 5-7 in hospital; 4 weeks after discharge

07

Study locations

1 of 1 sites recruiting
  • Ziekenhuis Oost-Limburg
    Genk, 3600, Belgium
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2017 (actual). Primary completion is estimated for Jul 2018, 9 months after the start.

Of 490 non-industry observational studies under Motor Activity, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 48. This study's planned 9 months is below that.

Counting every sponsor, half of 500 studies reached it within 22 months; a quarter within 8 and three quarters within 48.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 21, 2017
First posted
Aug 15, 2017
StartActual
Sep 8, 2017
Primary completionEst.
Jul 1, 2018
CompletionEst.
Jul 1, 2020
Last update
Sep 8, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 8, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03250000
Lead sponsor
Hasselt University
Responsible party
Martijn Spruit (PhD, Hasselt University) — Principal investigator
First posted
Aug 15, 2017
Start date
Sep 8, 2017
Primary completion
Jul 1, 2018 (estimated)
Completion
Jul 1, 2020 (estimated)
Last update
Sep 8, 2017

Study contacts

Chris Burtin, PhD
Contact
chris.burtin@uhasselt.be
0032499387898
Martijn Spruit, PhD
Contact
martijn.spruit@uhasselt.be
+32011269370

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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