Acute effects of whole-body vibration on arterial stiffness, blood pressure and flexibility in individuals with type 2 diabetes

Phase 2

• Conditions: Individuals with type 2 diabetes; Type 2 diabetes, arterial stiffness, flexibility, whole-body vibration, acute effect

• Registration Number: TCTR20221014009
• Lead Sponsor: Khon Kean University research grant KKU Scholarship for ASEAN and GMS Countries

Brief Summary

After 15 minutes and 45 minutes of whole-body vibration, there is a significant improvement in arterial stiffness, blood pressure, and flexibility in individuals who have type 2 diabetes.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-14
• Study Completion: 2023-10-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

1)Patients who had been diagnosed with T2DM between one and ten years before entering in this trial
2)Age between 44 to 64 years old (Shinan-Altman & Werner, 2019)
3)BMI 18.5 kg/m2 to 29.9 kg/m2 (Dufour et al., 2017)
4)According to the ACSM criteria, flexibility level is fair or poor by using the Sit-and-Reach test (Riebe et al., 2018)
5)Waist-to-height ratio < 0.5 (Browning et al., 2010)
6)Able to ambulate without any assistive devices, understand and follow instructions in research protocol

Exclusion Criteria

1)FBS > 300 mg/dL (Colberg et al., 2010)
2)SBP more than or equal to 140 mmHg and/or DBP more than or equal to 90 mmHg (James et al., 2014)
3)Lower extremity pain (VAS more than 3) at rest or in a high squat position (knee flexion at 120 degree)
4)Regular physical exercise (moderate intensity, more than or equal to 30 min/session, more than or equal to 3 sessions/week) (Montero et al., 2015)
5)Musculoskeletal problems (implants in trained body parts: artificial joints, acute inflammations of the musculoskeletal system, activated arthrosis or arthroplasty: acute swelling and inflammation of joints, acute tendinopathies in trained body parts: acute inflammation of tendons/ sinews, acute hernia: protrusion of tissue, acute discopathy: acute slipped disk, fresh fractures in trained body parts, rheumatoid arthritis) (Tomas et al., 2011)
6)Cardiovascular problems (acute thrombosis: acute vascular constriction) (Tomas et al., 2011)
7)Neurological problems (benign paroxysmal positional vertigo and epilepsy) (Tomas et al., 2011)
8)Retinopathy (Manimmanakorn et al., 2017)
9)Nephropathy (Manimmanakorn et al., 2017)
10)Acute edema at lower and upper extremities (Tomas et al., 2011)
11)Diabetic foot ulcer (Tomas et al., 2011)
12)Tumors or metastases (Tomas et al., 2011)
13)Gall, bladder, and kidney stones (Tomas et al., 2011)
14)Pregnant women (Tomas et al., 2011)
15)Women who have menstruation (Bruinvels et al., 2017)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Central arterial stiffness Before the intervention, 15 minutes and 45 minutes after the intervention Carotid femoral pulse wave velocity (cf-PWV)

Secondary Outcome Measures

Name	Time	Method
Blood pressure Before the intervention, 15 minutes and 45 minutes after the intervention Digital sphygmomanometer,Flexibility Before the intervention, 15 minutes and 45 minutes after the intervention Sit-and-reach test