Effect of Lifestyle Modification on Metabolic factors, Musculoskeletal Health, Reproductive Hormone and Quality of life in Older People Who have Diabetes, Hypertension or Dyslipidemia

Phase 1

• Conditions: DiabetesHypertensionDyslipidemia; diet; lifestyle modification; metabolic control; muscle strength; quality of life

• Registration Number: TCTR20210428005
• Lead Sponsor: ational Research Council of Thailand (NRCT)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-28
• Study Completion: 2022-06-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

(1) Thai Nationality, Aged 60-90 years old who live in communities in Bangkok
(2) Walking ability and self-care ability
(3) Patients diagnosed with high LDL-cholesterol level, diabetes mellitus, hypertension or one, that ongoing treatment in either hospital or other for at least 6 months prior to enrollment
(3.1) For patients with diabetes mellitus must have HbA1c level of 7.5-11% or an FPG level of 180 -300 mg/dL within last 6 months prior to enrollment
(3.2) For patients with dyslipidemia must have LDL-cholesterol level greater than or equal to 130 mg/dL within last 6 months prior to enrollment
(3.3) For patients with high blood pressure must have systolic pressure of 130-160 mmHg or diastolic pressure of 85-110 mmHg

Exclusion Criteria

(1) Patients with disease that makes the limitation of daily activities and vigorous-intensity exercise including heart disease, respiratory diseases, severe hypertension (blood pressure was higher than 180/110 mmHg), Kidney disease (eGFR < 45 ml/min)
(2) Patients with chronic muscle pain last longer than 3 months
(3) Resting EKG abnormalities (eg, left bundle branch block, paced rhythm, pre-excitation syndromes, or greater than or equal to 1-mm ST depression at rest)
(4) HbA1c level at start program higher than 11%

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Barthel Activities of Daily Living At 6 months and 12 months Change of Barthel ADL score at each time point,Sleep Quality At 6 months and 12 months Change of Pittsburgh Sleep Quality score at each time point,Quality of Life At 6 months and 12 months Change of EQ-5D-5L score at each time point

Secondary Outcome Measures

Name	Time	Method
metabolic parameters At 6 months and 12 months Change of metabolic parameters at each time point,Musculoskeletal Health At 6 months and 12 months Change of Body composition at each point