Acute effects of whole-body vibration on ankle systolic blood pressure and flexibility in individuals with type 2 diabetes

Phase 1

Completed

• Conditions: Individuals with type 2 diabetes; Type 2 diabetes, ankle systolic blood pressure, flexibility, whole-body vibration, acute effect

• Registration Number: TCTR20230125003
• Lead Sponsor: Khon Kean University research grant KKU Scholarship for ASEAN and GMS Countries

Brief Summary

After a seven-day washout period, neither group exhibited a carryover effect. At the post-intervention period, the WBV intervention resulted in a significant increase in flexibility and a significant decrease in ankle SBP and the ABI. In contrast, the NWBV intervention led to a significant increase in ankle SBP.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-25
• Study Completion: 2023-07-27
• Results First Posted: 2024-02-23
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

1) Patients who had been diagnosed with T2DM between one and ten years before entering in this trial
2) Age between 40 to 59 years old (Shinan-Altman & Werner, 2019)
3) BMI 18.5 kg/m2 to 29.9 kg/m2 (Dufour et al., 2017)
5) Able to ambulate without any assistive devices, understand and follow instructions in research protocol

Exclusion Criteria

1) Brachial SBP more than or equal to 140 mmHg and/or brachial DBP more than or equal to 90 mmHg (James et al., 2014)
2) Lower extremity pain (VAS more than 3) at rest or in a high squat position (knee flexion at 120 degree)
3) Regular physical exercise (moderate intensity, 3 to 6 METs, more than or equal to 30 min/session, more than or equal
to 3 sessions/week) (Montero et al., 2015)
4) 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)
5) Cardiovascular problems (acute thrombosis: acute vascular constriction) (Tomas et al., 2011)
6) Neurological problems (benign paroxysmal positional vertigo and epilepsy) (Tomas et al., 2011)
7) Retinopathy (Manimmanakorn et al., 2017)
8) Nephropathy (Manimmanakorn et al., 2017)
9) Acute edema at lower and upper extremities (Tomas et al., 2011)
10) Diabetic foot ulcer (Tomas et al., 2011)
11) Tumors or metastases (Tomas et al., 2011)
12) Gall, bladder, and kidney stones (Tomas et al., 2011)
13) Pregnant women (Tomas et al., 2011)
14) Women who have menstruation (Bruinvels et al., 2017)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ankle systolic blood pressure Before the intervention, 15 minutes and 45 minutes after the intervention Automatic sphygmomanometer

Secondary Outcome Measures

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