NCT06211686

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 28, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 18, 2024

Completed
14 days until next milestone

Study Start

First participant enrolled

February 1, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

January 18, 2024

Status Verified

January 1, 2024

Enrollment Period

10 months

First QC Date

December 28, 2023

Last Update Submit

January 16, 2024

Conditions

Keywords

SarcopeniaOlder peopleHealth Promotion ProgramPost COVID-19

Outcome Measures

Primary Outcomes (3)

  • 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 (1)

  • Prevalence of sarcopenia

    3 months

Study Arms (1)

Protein supplement and Resistance exercise

EXPERIMENTAL
Other: Protein powder and Resistance exercise

Interventions

1. Protein powder supplementation 25-30 g/day 2. Resistance exercise 2 time/week

Protein supplement and Resistance exercise

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Central Study Contacts

Wanabhorn Tongchom, Doctoral

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Phase I: Descriptive survey research Phase II: Quasi-experimental research
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

December 28, 2023

First Posted

January 18, 2024

Study Start

February 1, 2024

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

January 18, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share