Peripheral Arterial DiseaseNCT03458754
Maximal Exercise Capacity, Physical Activity and Respiratory Muscle Strength in Peripheral Artery Disease
An observational study of Peripheral Arterial Disease, run by Gazi University at 2 sites in Turkey (Türkiye).
Trial summary
The primary aim of the study is to evaluate the maximal and submaximal exercise capacity in patients with peripheral artery disease (PAD). The secondary aim of the study is assessment of physical activity level, respiratory function, peripheral and respiratory muscle strength, respiratory muscle endurance, depression… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Peripheral Arterial Disease
- How many people
- 35 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Jan 2018to 31 Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: At least 15 patients with PAD will be included in patients group and 15 healthy individuals will be included in control group
Who may be able to join
- Patients;
- Diagnosed with peripheral artery disease
- Ankle brachial index (ABI)≤ 1,5 or calcified vessel response
- Clinically stable and under standard medication patients will be included
Who cannot join
- Patients with;
- Ischemic amputation
- Any pulmonary disease
- Unstable coronary artery disease
- Orthopedic and neurological problems
- Acute infection
Show all 9Show fewer
- Myocardial infarction or major surgery in the last 3 months will be excluded
- Healthy controls: Ages 18-80 years will be included
- With any diagnosed disease and smoking more than 10 packsyears will be excluded
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Gazi University
Ankara, 06500
Gazi University Faculty of Health Sciences Department of Physical Therapy and Rehabilitation
Yenimahalle
About this study
Official title: Assessment of Exercise Capacity, Physical Activity, Pulmonary Function, Peripheric and Respiratory Muscle Strength, Respiratory Muscle Endurance in Patient With Peripheral Artery Disease
The primary aim of the study is to evaluate the maximal and submaximal exercise capacity in patients with peripheral artery disease (PAD). The secondary aim of the study is assessment of physical activity level, respiratory function, peripheral and respiratory muscle strength, respiratory muscle endurance, depression, quality of life, intermittent claudication and cardiovascular risk factors in patients with PAD.
Read the detailed description
Peripheral artery disease is characterized by reduced exercise capacity, physical activity level and intermittent claudication. The number of studies investigating maximal and submaximal exercise capacity and physical activity level in PAD is limited. There is also no study investigated pulmonary functions, respiratory muscle strength and endurance in this patient population. According to the sample size analysis 15 patients and 15 healthy individuals with similar demographic characteristics will be included the study. Patients and healthy individuals will be selected according to predetermined inclusion and exclusion criteria. The assessments will be completed in two days.Maximal exercise capacity will be assessed using cardiopulmonary exercise testing (CPET), functional exercise capacity using six minute stepper test, physical activity using multi-sensor activity monitor, pulmonary function using spirometry, respiratory muscle strength using mouth pressure device, peripheral muscle strength using hand held dynamometer, respiratory muscle endurance using incremental threshold loading test, depression using Beck depression inventory (Turkish version), life quality using SF-36 Health Survey (Turkish version), intermittent claudication using Walking Impairment Questionnaire (Turkish version)
- Conditions
- Peripheral Arterial Disease
- Keywords
- Peripheral Arterial Disease, Exercise capacity, Physical activity, Respiratory muscle strength, Peripheric muscle strength
- Medical subject headings
- Peripheral Arterial Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Maximal exercise capacity will be assessed using cardiopulmonary exercise testing (CPET), functional exercise capacity using six minute stepper test, physical activity using multi-sensor activity monitor, pulmonary function using spirometry, respiratory muscle strength using mouth pressure device, peripheral muscle strength using hand held dynamometer, respiratory muscle endurance using incremental threshold loading test, depression using Beck depression inventory (Turkish version), life quality using SF-36 Health Survey (Turkish version), intermittent claudication using Walking Impairment Questionnaire (Turkish version) | |
| Healthy controls | Maximal exercise capacity will be assessed using cardiopulmonary exercise testing (CPET), functional exercise capacity using six minute stepper test, physical activity using multi-sensor activity monitor, pulmonary function using spirometry, respiratory muscle strength using mouth pressure device, peripheral muscle strength using hand held dynamometer, respiratory muscle endurance using incremental threshold loading test, depression using Beck depression inventory (Turkish version), life quality using SF-36 Health Survey (Turkish version), intermittent claudication using Walking Impairment Questionnaire (Turkish version) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal exercise capacity
Cardiopulmonary exercise testing (Oxygen consumption measurement during test)
Measured: First day
Secondary outcomes (9)
Functional exercise capacity
Six minute stepper test
Measured: Second day
Physical activity
Multi sensor activity monitor
Measured: Second day
Pulmonary function
Spirometry
Measured: First day
Respiratory muscle strength
Mouth pressure device
Measured: First day
Peripheral muscle strength
Hand held dynamometer
Measured: Second day
Respiratory muscle endurance
Incremental threshold loading test
Measured: Second day
Depression
Beck depression inventory (Turkish version)
Measured: Second day
Life quality
SF-36 Health Survey (Turkish version)
Measured: Second day
Intermittent claudication
Walking Impairment Questionnaire (Turkish version)
Measured: Second day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2018
- Study start1 Jan 2018
- Primary completion31 Dec 2018
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meral Boşnak Güçlü, Gazi University
- Investigators
- İnci Hazal Ayas, MSc, Study chair, Gazi UniversityMeral Boşnak Güçlü, Assoc. Prof, Study director, Gazi UniversityBurcu Camcıoğlu, PhD, Principal investigator, Gazi UniversityDilek Erer, MD, Principal investigator, Gazi UniversityAbdullah Özer, MD, Principal investigator, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03458754
- Sponsor's protocol ID
- Gazi University 9
- Status last verified
- Nov 2020
- First submitted
- 2 Mar 2018
- Last updated
- 24 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Leeper NJ, Myers J, Zhou M, Nead KT, Syed A, Kojima Y, Caceres RD, Cooke JP. Exercise capacity is the strongest predictor of mortality in patients with peripheral arterial disease. J Vasc Surg. 2013 Mar;57(3):728-33. doi: 10.1016/j.jvs.2012.07.051. Epub 2012 Oct 6.
PubMed 23044259Pande RL, Perlstein TS, Beckman JA, Creager MA. Secondary prevention and mortality in peripheral artery disease: National Health and Nutrition Examination Study, 1999 to 2004. Circulation. 2011 Jul 5;124(1):17-23. doi: 10.1161/CIRCULATIONAHA.110.003954. Epub 2011 Jun 20.
PubMed 21690489Nordanstig J, Broeren M, Hensater M, Perlander A, Osterberg K, Jivegard L. Six-minute walk test closely correlates to "real-life" outdoor walking capacity and quality of life in patients with intermittent claudication. J Vasc Surg. 2014 Aug;60(2):404-9. doi: 10.1016/j.jvs.2014.03.003. Epub 2014 Mar 29.
PubMed 24690492Colas-Ribas C, Signolet I, Henni S, Feuillloy M, Gagnadoux F, Abraham P. High prevalence of known and unknown pulmonary diseases in patients with claudication during exercise oximetry: A retrospective analysis. Medicine (Baltimore). 2016 Oct;95(40):e4888. doi: 10.1097/MD.0000000000004888.
PubMed 27749546Sieminski DJ, Gardner AW. The relationship between free-living daily physical activity and the severity of peripheral arterial occlusive disease. Vasc Med. 1997 Nov;2(4):286-91. doi: 10.1177/1358863X9700200402.
PubMed 9575600Gardner AW, Montgomery PS, Scott KJ, Blevins SM, Afaq A, Nael R. Association between daily ambulatory activity patterns and exercise performance in patients with intermittent claudication. J Vasc Surg. 2008 Nov;48(5):1238-44. doi: 10.1016/j.jvs.2008.06.062. Epub 2008 Sep 4.
PubMed 18771878
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Exercise Capacity, Physical Activity, Pulmonary Function, Peripheric and Respiratory Muscle Strength, Respiratory Muscle Endurance in Patient With Peripheral Artery Disease
- ClinicalTrials.gov ID
- NCT03458754
- Acronym / sponsor ID
- Gazi University 9
- Conditions
- Peripheral Arterial Disease
- Keywords
- Peripheral Arterial Disease, Exercise capacity, Physical activity, Respiratory muscle strength, Peripheric muscle strength
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 8 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary aim of the study is to evaluate the maximal and submaximal exercise capacity in patients with peripheral artery disease (PAD). The secondary aim of the study is assessment of physical activity level, respiratory function, peripheral and respiratory muscle strength, respiratory muscle endurance, depression, quality of life, intermittent claudication and cardiovascular risk factors in patients with PAD.
Detailed description
Peripheral artery disease is characterized by reduced exercise capacity, physical activity level and intermittent claudication. The number of studies investigating maximal and submaximal exercise capacity and physical activity level in PAD is limited. There is also no study investigated pulmonary functions, respiratory muscle strength and endurance in this patient population. According to the sample size analysis 15 patients and 15 healthy individuals with similar demographic characteristics will be included the study. Patients and healthy individuals will be selected according to predetermined inclusion and exclusion criteria. The assessments will be completed in two days.Maximal exercise capacity will be assessed using cardiopulmonary exercise testing (CPET), functional exercise capacity using six minute stepper test, physical activity using multi-sensor activity monitor, pulmonary function using spirometry, respiratory muscle strength using mouth pressure device, peripheral muscle strength using hand held dynamometer, respiratory muscle endurance using incremental threshold loading test, depression using Beck depression inventory (Turkish version), life quality using SF-36 Health Survey (Turkish version), intermittent claudication using Walking Impairment Questionnaire (Turkish version)
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | –Maximal exercise capacity will be assessed using cardiopulmonary exercise testing (CPET), functional exercise capacity using six minute stepper test, physical activity using multi-sensor activity monitor, pulmonary function using spirometry, respiratory muscle strength using mouth pressure device, peripheral muscle strength using hand held dynamometer, respiratory muscle endurance using incremental threshold loading test, depression using Beck depression inventory (Turkish version), life quality using SF-36 Health Survey (Turkish version), intermittent claudication using Walking Impairment Questionnaire (Turkish version) |
| Healthy controls | – | –Maximal exercise capacity will be assessed using cardiopulmonary exercise testing (CPET), functional exercise capacity using six minute stepper test, physical activity using multi-sensor activity monitor, pulmonary function using spirometry, respiratory muscle strength using mouth pressure device, peripheral muscle strength using hand held dynamometer, respiratory muscle endurance using incremental threshold loading test, depression using Beck depression inventory (Turkish version), life quality using SF-36 Health Survey (Turkish version), intermittent claudication using Walking Impairment Questionnaire (Turkish version) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- At least 15 patients with PAD will be included in patients group and 15 healthy individuals will be included in control group
Key inclusion criteria (4 listed)
- Patients;
- Diagnosed with peripheral artery disease
- Ankle brachial index (ABI)≤ 1,5 or calcified vessel response
- Clinically stable and under standard medication patients will be included
Key exclusion criteria (9 listed)
- Patients with;
- Ischemic amputation
- Any pulmonary disease
- Unstable coronary artery disease
- Orthopedic and neurological problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Maximal exercise capacity
Time frame: First day
Cardiopulmonary exercise testing (Oxygen consumption measurement during test)
9 secondary outcomes
Functional exercise capacity
Time frame: Second day
Physical activity
Time frame: Second day
Pulmonary function
Time frame: First day
Respiratory muscle strength
Time frame: First day
Peripheral muscle strength
Time frame: Second day
Respiratory muscle endurance
Time frame: Second day
Depression
Time frame: Second day
Life quality
Time frame: Second day
Intermittent claudication
Time frame: Second day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2020.
- Background: PubMed 23044259Leeper NJ, Myers J, Zhou M, Nead KT, Syed A, Kojima Y, Caceres RD, Cooke JP. Exercise capacity is the strongest predictor of mortality in patients with peripheral arterial disease. J Vasc Surg. 2013 Mar;57(3):728-33. doi: 10.1016/j.jvs.2012.07.051. Epub 2012 Oct 6.
- Background: PubMed 21690489Pande RL, Perlstein TS, Beckman JA, Creager MA. Secondary prevention and mortality in peripheral artery disease: National Health and Nutrition Examination Study, 1999 to 2004. Circulation. 2011 Jul 5;124(1):17-23. doi: 10.1161/CIRCULATIONAHA.110.003954. Epub 2011 Jun 20.
- Background: PubMed 24690492Nordanstig J, Broeren M, Hensater M, Perlander A, Osterberg K, Jivegard L. Six-minute walk test closely correlates to "real-life" outdoor walking capacity and quality of life in patients with intermittent claudication. J Vasc Surg. 2014 Aug;60(2):404-9. doi: 10.1016/j.jvs.2014.03.003. Epub 2014 Mar 29.
- Background: PubMed 27749546Colas-Ribas C, Signolet I, Henni S, Feuillloy M, Gagnadoux F, Abraham P. High prevalence of known and unknown pulmonary diseases in patients with claudication during exercise oximetry: A retrospective analysis. Medicine (Baltimore). 2016 Oct;95(40):e4888. doi: 10.1097/MD.0000000000004888.
- Background: PubMed 9575600Sieminski DJ, Gardner AW. The relationship between free-living daily physical activity and the severity of peripheral arterial occlusive disease. Vasc Med. 1997 Nov;2(4):286-91. doi: 10.1177/1358863X9700200402.
- Background: PubMed 18771878Gardner AW, Montgomery PS, Scott KJ, Blevins SM, Afaq A, Nael R. Association between daily ambulatory activity patterns and exercise performance in patients with intermittent claudication. J Vasc Surg. 2008 Nov;48(5):1238-44. doi: 10.1016/j.jvs.2008.06.062. Epub 2008 Sep 4.
- Individual participant dataSharing planned: No
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Peripheral Arterial Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
İnci Hazal Ayas, MSc study chair
Gazi University
Meral Boşnak Güçlü, Assoc. Prof study director
Gazi University
Burcu Camcıoğlu, PhD principal investigator
Gazi University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Arterial Disease, run by Gazi University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal exercise capacity (time frame: First day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03458754, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2020.