An interventional study of Exercise in Peripheral Arterial Disease, sponsored by University of Nove de Julho. Enrolling by invitation at 1 site in Brazil. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-13.
Sponsored by University of Nove de Julho · Not applicable, Interventional, and Treatment
INTRODUCTION: Exercise with an arm ergometer (EB) overcomes the main barrier to physical exercise in patients with Peripheral Artery Disease (PAD), leg pain during walking. Due to its aerobic nature, this type of exercise can cause systemic changes in the regulatory mechanisms of vasodilation. In other words, it provides vascular benefits in the most affected arterial beds in the PAD population. OBJECTIVE: To analyze local and systemic vascular responses, as well as cell signaling pathways after an EB exercise session in patients with PAD and their peers without PAD. METHODS: 24 patients with PAD and 24 individuals without PAD will be recruited, matched by sex and age. Participants will undergo two experimental sessions in approved order (EB and control). The EB session will consist of 15 cycles of 2 min of exercise with an intensity equivalent to 13-15 on the Borg scale of perceived exertion. Before and after the experimental sessions, the vascular function of the brachial and femoral arteries, blood indicators of vasodilation and calf muscle oxygenation will be evaluated. To analyze the acute effect between groups on cardiovascular parameters, a three-way analysis of variance will be performed, taking as factors disease (presence vs. absence), session (EB vs. Control) and time (pre vs. post). In all analyses, when a significant effect is selected, the Bonferroni or Newman-Keuls post-hoc test will be used. For all analyses, a value of P\<0.05 will be considered significant.
1,377 studies on the registry are indexed under Peripheral Arterial Disease; 275 are open to participants now.
This study's planned enrollment of 24 is below the median of 70 across 927 interventional studies indexed under Peripheral Arterial Disease.
Browse Peripheral Arterial Disease studies →University of Nove de Julho is the lead sponsor of 246 studies on the registry; 52 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 1 (13%) have results posted.
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Exclusion Criteria:
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.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
In the arm-cranking condition, the patients will perform fifteen bouts of two minutes of arm-cranking with an interval of two minutes between bouts, at an intensity equivalent to 13-15 on Borg's subjective perceived exertion scale. The condition will have a total of sixty minutes of duration.
Behavioral: Exercise
The control condition will consist of resting in the standing position for thirty minutes. The patients will be instructed to rest in the sitting position for two minutes at periods equivalent to the intervals from the exercise conditions, totalling sixty minutes of duration.
Behavioral: Exercise
Two conditions will be tested: Arm-cranking and control condition.
Calf Muscle Oxygen Saturation (%)
The parameters of calf muscle oxygenation will be collected using the non-invasive Near-Infrared Spectroscopy (NIRS) technique, with an NIRS spectrometer and a dedicated laptop computer. The NIRS sensor will be placed on the calf region, on the leg with the lower ankle brachial index, at the level of the largest calf circumference. The equipment will be programmed for continuous recording throughout the experimental session, covering the pre-exercise, during exercise with arm ergometer, and post-exercise periods.
Time frame: Just before, during 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30 minutes of exercise, and after 10 minutes of exercise.
Change from baseline in vascular function post-exercise in the brachial and femoral arteries (%).
Vascular function will be measured in the supine position by the flow-mediated dilation (FMD) technique, through Doppler ultrasonography.
Time frame: Before and after 40 minutes of exercise.
Oxyhemoglobin (micromol)
The parameters of calf muscle oxygenation will be collected using the non-invasive Near-Infrared Spectroscopy (NIRS) technique, with an NIRS spectrometer and a dedicated laptop computer. The NIRS sensor will be placed on the calf region, on the leg with the lower ankle brachial index, at the level of the largest calf circumference. The equipment will be programmed for continuous recording throughout the experimental session, covering the pre-exercise, during exercise with arm ergometer, and post-exercise periods.
Time frame: Just before, during 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30 minutes of exercise, and after 10 minutes of exercise.
Deoxyhemoglobin (micromol)
The parameters of calf muscle oxygenation will be collected using the non-invasive Near-Infrared Spectroscopy (NIRS) technique, with an NIRS spectrometer and a dedicated laptop computer. The NIRS sensor will be placed on the calf region, on the leg with the lower ankle brachial index, at the level of the largest calf circumference. The equipment will be programmed for continuous recording throughout the experimental session, covering the pre-exercise, during exercise with arm ergometer, and post-exercise periods.
Time frame: Just before, during 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30 minutes of exercise, and after 10 minutes of exercise.
Total hemoglobin (micromol)
The parameters of calf muscle oxygenation will be collected using the non-invasive Near-Infrared Spectroscopy (NIRS) technique, with an NIRS spectrometer and a dedicated laptop computer. The NIRS sensor will be placed on the calf region, on the leg with the lower ankle brachial index, at the level of the largest calf circumference. The equipment will be programmed for continuous recording throughout the experimental session, covering the pre-exercise, during exercise with arm ergometer, and post-exercise periods.
Time frame: Just before, during 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30 minutes of exercise, and after 10 minutes of exercise.
Nitric oxide production markers (micromol)
Before and after the sessions, a venous blood sample (10 mL) will be collected in tubes containing Ethylenediaminetetraacetic Acid (EDTA). Plasma will be immediately obtained after refrigerated centrifugation and used for the determination of thiobarbituric acid reactive substances (TBARS), nitrite, and nitrate (Griess test, Sigma Aldrich), as well as for biochemical analyses of lipids (cholesterol, triglycerides, High-Density Lipoprotein (HDL) cholesterol, and Low-Density Lipoprotein (LDL) cholesterol calculation) and glucose levels. Glycated hemoglobin will be determined in whole blood by high-performance liquid chromatography. Cultured human umbilical vein endothelial cells (HUVEC) will be incubated with 0.2% plasma obtained from all individuals for different time intervals. Indicators of nitric oxide production will be determined in the cells (cGMP concentration and endothelial nitric oxide synthase \[eNOS\] expression) and in the culture medium (nitrite/nitrate concentration).
Time frame: Before and after 5 minutes of exercise.
Plan to share: Yes — Individual data may be disclosed upon contact with the principal investigator.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
No publications or documents are linked to this record.
Started Mar 2025 (actual). Primary completion is estimated for Jul 2027, 27 months after the start.
Of 260 non-industry interventional studies with no phase under Peripheral Arterial Disease, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 64. This study's planned 27 months is below that.
Counting every sponsor, half of 385 studies reached it within 31 months; a quarter within 17 and three quarters within 55.
How these figures are worked out, and which studies are left out of them.
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