Diabetes MellitusNCT06292624
Effectiveness of Intermittent Vacuum Therapy Combined with Aerobic Exercise in Individuals with Diabetes Mellitus
A study testing Intermittent vacuum therapy (Weyergans High Care® Medial, Germany) and Cycling exercise in people with Diabetes Mellitus, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 55 to 80 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Intermittent vacuum therapy (Weyergans High Care® Medial, Germany) and Cycling exercise
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Aug 2023to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 55 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age between 55 and 80 years old,
- being diagnosed with Type 2 DM,
- being able to give informed consent to participate in the study.
- able to walk without assistance
Who cannot join
- have a conditions that contraindications to IVT: pregnancy, abdominal wall hernia, recent (<8 weeks) trauma of the lower limbs,
- have an open wound on the lower extremity or with lower extremity infection,
- have any orthopaedic or medical conditions that could hinder the assessment and training.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Intermittent Vacuum Therapy Combined with Aerobic Exercise in Improving Lower Limb Oxygenation and Circulation in Individuals with Diabetes Mellitus
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.
Read the detailed description
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.
- Conditions
- Diabetes Mellitus
- Being tested
- Intermittent vacuum therapy (Weyergans High Care® Medial, Germany), Cycling exercise
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent vacuum therapy (Weyergans High Care® Medial, Germany)Device
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.
Cycling exerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intermittent vacuum therapy + Cycling exercise | Experimental | Participants received 12 IVT sessions of 30 minutes combined with 20 minutes of cycling exercise during the 6-week period. Receives: Device: Intermittent vacuum therapy (Weyergans High Care® Medial, Germany); Behavioral: Cycling exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: post-treatment (6weeks)
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: post-treatment (6weeks)
Functional mobility
Functional mobility will be assessed by the Timed Up and Go Test
Measured: baseline
Functional mobility
Functional mobility will be assessed by the Timed Up and Go Test
Measured: post-treatment (6weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start1 Aug 2023
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Clinical trials with a single arm, receiving IVT combined with cycling exercise
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- Yan Chai Hospital Social Services
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06292624
- Sponsor's protocol ID
- HSEARS20230417002
- Status last verified
- Feb 2025
- First submitted
- 27 Feb 2024
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Intermittent Vacuum Therapy Combined with Aerobic Exercise in Improving Lower Limb Oxygenation and Circulation in Individuals with Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT06292624
- Acronym / sponsor ID
- HSEARS20230417002
- Conditions
- Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 12 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- Yan Chai Hospital Social Services
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 5 Mar 2024 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Clinical trials with a single arm, receiving IVT combined with cycling exercise
| Arm | Type | Receives |
|---|---|---|
| Intermittent vacuum therapy + Cycling exercise | Experimental | Device: Intermittent vacuum therapy (Weyergans High Care® Medial, Germany), Behavioral: Cycling exerciseParticipants received 12 IVT sessions of 30 minutes combined with 20 minutes of cycling exercise during the 6-week period. |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age between 55 and 80 years old,
- being diagnosed with Type 2 DM,
- being able to give informed consent to participate in the study.
- able to walk without assistance
Key exclusion criteria (3 listed)
- have a conditions that contraindications to IVT: pregnancy, abdominal wall hernia, recent (<8 weeks) trauma of the lower limbs,
- have an open wound on the lower extremity or with lower extremity infection,
- have any orthopaedic or medical conditions that could hinder the assessment and training.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intermittent vacuum therapy (Weyergans High Care® Medial, Germany)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. | Device | Intermittent vacuum therapy + Cycling exercise |
| Cycling exerciseThe 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. | Behavioural | Intermittent vacuum therapy + Cycling exercise |
Primary outcome
Muscle oxygenation
Time frame: baseline
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.
Muscle oxygenation
Time frame: post-treatment (6weeks)
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.
8 secondary outcomes
Surface Electromyography
Time frame: baseline
Surface Electromyography
Time frame: post-treatment (6weeks)
Foot Sensation
Time frame: baseline
Foot Sensation
Time frame: post-treatment (6weeks)
Functional muscle strength
Time frame: baseline
Functional muscle strength
Time frame: post-treatment (6weeks)
Functional mobility
Time frame: baseline
Functional mobility
Time frame: post-treatment (6weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Individual participant dataSharing planned: No. Individual participant data will not be shared to other researchers
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent vacuum therapy (Weyergans High Care® Medial, Germany) and Cycling exercise in people with Diabetes Mellitus, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
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 3 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: under way, not looking for participants, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. 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?
This study is still under way. Results are not available in the source record yet.
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?
Muscle oxygenation (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Mar 2025.