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

January 16, 2024 updated by: Wanabhorn Tongchom, Mahidol University
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Protein supplement and Resistance exercise
Other: Protein powder and Resistance exercise
  1. Protein powder supplementation 25-30 g/day
  2. Resistance exercise 2 time/week

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Prevalence of sarcopenia
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Collaborators

National Health Security Office, Thailand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2024

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

December 28, 2023

First Submitted That Met QC Criteria

January 16, 2024

First Posted (Actual)

January 18, 2024

Study Record Updates

Last Update Posted (Actual)

January 18, 2024

Last Update Submitted That Met QC Criteria

January 16, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MURA2023/918
  • 2023/918 (Other Identifier: MURA)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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