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

NCT06292624 | Active Not Recruiting

• 1 other identifier: HSEARS20230417002
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (8)

• Surface Electromyography

  baseline

• Surface Electromyography

  post-treatment (6weeks)

• Foot Sensation

  baseline

• Foot Sensation

  post-treatment (6weeks)

• Functional muscle strength

  baseline

Study Arms (1)

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.

Device: Intermittent vacuum therapy (Weyergans High Care® Medial, Germany); Behavioral: Cycling exercise

Interventions

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.

Intermittent vacuum therapy + Cycling exercise

Cycling exercise BEHAVIORAL

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.

Intermittent vacuum therapy + Cycling exercise

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead
• Yan Chai Hospital Social Services: collaborator

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Clinical trials with a single arm, receiving IVT combined with cycling exercise

Study Record Dates

• First Submitted: February 27, 2024
• First Posted: March 5, 2024
• Study Start: August 1, 2023
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: March 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)