The Effectiveness of a Health Promotion Program for Older... | NCT06211686

Studies
The Effectiveness of a Health Promotion Program for Older People With Post-Covid-19 Sarcopenia

NCT06211686

Sponsor

Mahidol University

Status

Unknown status

Last Update Posted

Jan 18, 2024Actual

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Post COVID-19 Condition

Interventions

Protein powder and Resistance exercise

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2023/918	Other Identifier	MURA

Status Module

Record Verification Date

Jan 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2024Estimated

Primary Completion Date

Dec 1, 2024Estimated

Completion Date

Dec 1, 2024Estimated

First Submitted Date

Dec 28, 2023

First Submission Date that Met QC Criteria

Jan 16, 2024

First Posted Date

Jan 18, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 16, 2024

Last Update Posted Date

Jan 18, 2024Actual

Name	Class
National Health Security Office, Thailand	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of this clinical trial is to investigate the prevalence of sarcopenia in older people with post-COVID-19 living in Ratchatewi district, Bangkok and to test the effectiveness of health promotion program for older people with post-COVID-19 Sarcopenia. The main questions it aim to answer are: • How many is the prevalence of sarcopenia in older people with post-COVID-19 living in Ratchatewi district, Bangkok? • Can the health promotion program improve muscle mass and muscle strength in older people with post-COVID-19 Sarcopenia ? Participants will be asked eating protein supplement one scoop /day and exercising 2 times/week for 3 months.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Protein supplement and Resistance exercise	Experimental		Other: Protein powder and Resistance exercise

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Protein powder and Resistance exercise	Other	Protein powder supplementation 25-30 g/day Resistance exercise 2 time/week	Protein supplement and Resistance exercise

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Muscle mass	Muscle mass will be measured using BIA and calf circumference in kilograms.	3 months
Muscle strength	Muscle strength will be assessed using hand grip strength in kilograms.	3 motnhs
Physical fitness	Physical fitness will be measured using the Five Times Sit to Stand Test (FTSST) in second.	3 months

Secondary Outcomes

Measure	Description	Time Frame
Prevalence of sarcopenia		3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Older people with post-COVID-19 sarcopenia aged more than and equal 60 years
No disabilities
Able to read, write and communicate Thai langue
Live in Bangkok
Moderate post-covid-19 state defined by Thai version of the COVID-19 Yorkshire Rehabilitation Scale
No soy protein allergy
Sign inform consent

Exclusion Criteria:

Severe post-covid-19 state defined by Thai version of the COVID-19 Yorkshire Rehabilitation Scale and complicated health problems
Disabilities
Unable to read, write and communicate Thai langue
Soy protein allergy
CKD 4 and CKD 5
Deny or withdraw from project

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Wanabhorn Tongchom, Doctoral	Contact	022012652		wanabhorntc@gmail.com

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D055948	Sarcopenia

Ancestor Terms

ID	Term
D009133	Muscular Atrophy
D020879	Neuromuscular Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided