An interventional study of Intermittent vacuum therapy (Weyergans High Care® Medial, Germany) and Cycling exercise in Diabetes Mellitus, sponsored by The Hong Kong Polytechnic University. Active, not recruiting at 1 site in Hong Kong. Open to participants aged 55 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-03-12.
Sponsored by The Hong Kong Polytechnic University · Not applicable, Interventional, and Treatment
Consequences of the compromised vascular system in diabetes mellitus (DM) are among the most devastating complications. Reduction in blood flow and oxygen uptake of skeletal muscle leads to muscle fatigue and impaired skeletal muscle post-exercise adaptation. Recent studies showed that intermittent vacuum therapy (IVT) augments the blood flow of the foot in people with DM. This pilot study investigates the effects of combined IVT and aerobic exercise in improving lower limb muscle oxygenation and distal circulation in individuals with DM. Positive results of the study shed light on strategy that enhances the effectiveness of aerobic exercise in people with DM.
This study addresses the significant global health issue of Diabetes Mellitus (DM), a chronic condition characterized by the body's inability to properly use and store glucose. With an estimated 422 million adults affected worldwide in 2014, projected to increase to 629 million by 2045, DM poses a substantial public health challenge. Specifically, in Hong Kong, the prevalence was around 8.4% in 2014, and by 2021, DM had become the tenth leading cause of death. One of the most devastating complications of DM is the damage to the vascular system.
Recent developments in treatment options include Intermittent Vacuum Therapy (IVT), a technique initially developed for astronauts to mitigate orthostatic complications. IVT involves the application of alternating negative and ambient pressures to the lower extremities, which has been shown to enhance blood flow by promoting rhythmic vasodilation and compression. This method has successfully increased foot perfusion in both healthy volunteers and patients with Peripheral Artery Disease (PAD), highlighting its potential benefits in improving circulation without direct contact with the patient's limb, thereby minimizing the risk of cross-infection.
The study also explores the role of aerobic exercise in improving insulin sensitivity, blood sugar control, and reducing DM-related complications. However, DM patients often face challenges such as muscle fatigue during exercise due to impaired glucose uptake, mitochondrial dysfunction, microvascular damage, and atherosclerosis, which limit blood supply to skeletal muscles, affecting exercise capacity.
Given the positive effects of IVT on distal circulation in PAD patients but its unexplored benefits in DM patients when combined with aerobic exercise, the study hypothesizes that IVT could enhance distal circulation, oxygen uptake, and nutrient delivery to the skeletal muscle of the lower limbs. This could, in turn, amplify the benefits of aerobic training on skeletal muscle in DM patients.
The study's objectives are twofold:
To evaluate the feasibility, safety, and patient acceptance of combining IVT with an exercise program in DM rehabilitation.
To examine the effectiveness of this combined approach on lower-limb perfusion, muscle physiology, and locomotion functions in DM patients.
10,926 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 12 is below the median of 80 across 8,368 interventional studies indexed under Diabetes Mellitus.
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Exclusion Criteria:
Participants received 12 IVT sessions of 30 minutes combined with 20 minutes of cycling exercise during the 6-week period.
Device: Intermittent vacuum therapy (Weyergans High Care® Medial, Germany) · Behavioral: Cycling exercise
The participants' lower limb will be placed in the vacuum chamber and sealed with a cuff. The maximum negative pressure applied in the experimental group would be -40mmHg (negative pressure/ambient pressure phase: 9s / 7s). The parameters are selected based on the manufacturer's recommendations.
The participant will perform 20 minutes of cycling exercise. Aiming at reaching a moderate exercise intensity (50% - 70%) of maximal heart rate on a gym bike.
Muscle oxygenation
Two wireless NIRS (Near-infrared Spectroscopy) sensors (Portamon, Artinis Medical Systems,The Netherlands) will be placed on participants' dorsal feet and quadriceps on their dominant leg. The signal will be collected continuously for 10 minutes during cycling.
Time frame: baseline
Muscle oxygenation
Two wireless NIRS sensors (Portamon, Artinis Medical Systems,The Netherlands) will be placed on participants' dorsal feet and quadriceps on their dominant leg. The signal will be collected continuously for 10 minutes during cycling.
Time frame: post-treatment (6weeks)
Surface Electromyography
Muscle fatigue of the quadriceps and calf muscles during cycling exercise will be quantified by the median frequency and mean power frequency extracted from surface electromyography signal.
Time frame: baseline
Surface Electromyography
Muscle fatigue of the quadriceps and calf muscles during cycling exercise will be quantified by the median frequency and mean power frequency extracted from surface electromyography signal.
Time frame: post-treatment (6weeks)
Foot Sensation
The monofilament test, which involves pointing a nylon filament over various areas of the foot to test for the ability to detect light touch, will be used to assess the foot sensory. It is considered a reliable method to detect the presence of peripheral neuropathy.
Time frame: baseline
Foot Sensation
The monofilament test, which involves pointing a nylon filament over various areas of the foot to test for the ability to detect light touch, will be used to assess the foot sensory. It is considered a reliable method to detect the presence of peripheral neuropathy.
Time frame: post-treatment (6weeks)
Functional muscle strength
The functional muscle strength will be assessed by the Five-Time Sit-to-Stand Test.The functional muscle strength will be assessed by the Five-Time Sit-to-Stand Test. Assessing the completion time of 5 sit-to-stand movement.
Time frame: baseline
Functional muscle strength
The functional muscle strength will be assessed by the Five-Time Sit-to-Stand Test. Assessing the completion time of 5 sit-to-stand movement.
Time frame: post-treatment (6weeks)
Functional mobility
Functional mobility will be assessed by the Timed Up and Go Test
Time frame: baseline
Functional mobility
Functional mobility will be assessed by the Timed Up and Go Test
Time frame: post-treatment (6weeks)
Plan to share: No — Individual participant data will not be shared to other researchers
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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The Hong Kong Polytechnic University