Effectiveness of Intermittent Vacuum Therapy Combined With Aerobic Exercise in Individuals With Diabetes Mellitus

Diabetes Mellitus Clinical Trial

Official title:

Effectiveness of Intermittent Vacuum Therapy Combined With Aerobic Exercise in Improving Lower Limb Oxygenation and Circulation in Individuals With Diabetes Mellitus

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06292624
• Other study ID #: HSEARS20230417002
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: April 30, 2024

Study information

• Verified date: February 2024
• Source: The Hong Kong Polytechnic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 12
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Device:
• 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.

Behavioral:
• Cycling exercise
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.

Locations

Country	Name	City	State
Hong Kong	The Hong Kong Polytechnic University	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University	Yan Chai Hospital Social Services

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline
Primary	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.	post-treatment (6weeks)
Secondary	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.	baseline
Secondary	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.	post-treatment (6weeks)
Secondary	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.	baseline
Secondary	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.	post-treatment (6weeks)
Secondary	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.	baseline
Secondary	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.	post-treatment (6weeks)
Secondary	Functional mobility	Functional mobility will be assessed by the Timed Up and Go Test	baseline
Secondary	Functional mobility	Functional mobility will be assessed by the Timed Up and Go Test	post-treatment (6weeks)