Effects of a Multi-intervention Programme for the Elderly

Effects of a Multi-intervention Programme on the Muscle Strength, Body Composition, Physical Performance and Quality of Life of the Elderly

1. To develop a multiactivity training programme. 2. To explore the effect of this programme on sarcopenia, sarcopenic obesity, cognitive impairment and Parkinson's disease. 3. To compare the effects of the experimental and control treatments on the muscle strength, body composition, physical function performance and quality of life of the elderly.

Study Overview

• Status: Completed
• Conditions: Dementia; Sarcopenia; Sarcopenic Obesity
• Intervention / Treatment: Dietary supplement: protein supplementation; Behavioral: muscle strength training; Other: usual care

• Study Type: Interventional
• Enrollment (Actual): 207
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taichung, Taiwan
    • Daycare center at Central Taiwan University of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

(1) over 60 years old, (2) able to Communicate and follow instructions; (3) Stable condition with sufficient physical strength: able to maintain a seated position in a wheelchair or on the edge of a bed for at least one hour. (4) sarcopenia, sarcopenic obesity, cognitive impairment and Parkinson's disease.

Exclusion Criteria:

(1) difficulty in standing or walking and obvious musculoskeletal disease, (2) unsuitable for diagnosis by a physician those engaged in sports activities, (3) serious diseases/unstable states, such as severe heart, lung, liver and kidney diseases, severe malignant tumors, severe nutrition poor, severe dementia, (4) more than 180 minutes of exercise per week in the past month, (5) no willingness to participate.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: muscle strength training and protein supplementation	Dietary supplement: protein supplementation; protein supplementation for 16 weeks; Behavioral: muscle strength training; muscle strength training for 16 weeks
Placebo Comparator: usual care	Other: usual care; no intervention
Experimental: muscle strength training	Behavioral: muscle strength training; muscle strength training for 16 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chang in muscle strength from baseline to 16 weeks	pinch, grip and quadriceps strength. A Higher score means a better outcome.	Baseline and 16 weeks
Chang in weight of muscle and fat from baseline to 16 weeks	muscle mass(kg), fat mass (kg)	Baseline and 16 weeks
Chang in Activities of Daily Living from baseline to 16 weeks	This is a scale of physical function. The range for total score is 0-100. A Higher score means a worse outcome.	Baseline and 16 weeks
Chang in Instrumental activities of daily living from baseline to 16 weeks	This is a scale of physical function. The range for total score is 0-24. A Higher score means a better outcome.	Baseline and 16 weeks
Chang in Clinical Dementia Rating from baseline to 16 weeks	Mental Function Assessment. The range is 0-3. A Higher score means a worse outcome.	Baseline and 16 weeks
Chang in Cornell Scale for Depression in Dementia from baseline to 16 weeks	Mental Function Assessment. The range for total score is 0-38. A Higher score means a worse outcome.	Baseline and 16 weeks
Chang in Cohen-Mansfield Agitation Inventory from baseline to 16 weeks	This is a scale of behavior measurement. The range for total is 29-203. A higher score means a worse outcome.	Baseline and 16 weeks
Chang in EQ5D from baseline to 16 weeks	This is a scale of quality of life. The range for total is 0-20. A higher score means a worse outcome.	Baseline and 16 weeks
Chang in QUALIDEM from baseline to 16 weeks	The scale is a dementia-specific Qol instrument. The range for total score is 0-120. A higher score means a better outcome.	Baseline and 16 weeks
Demographic attributes	Gender, education, age, married status, religion, medication, diseases, work and height.	Baseline
Chang in PERSONAL WELLBEING INDEX from baseline to 16 weeks	The range for total is 0-80. A higher score means a better outcome.	Baseline and 16 weeks
Chang in PERSONAL WELLBEING INDEX intellectual disability from baseline to 16 weeks	The range for total is 0-70. A higher score means a better outcome.	Baseline and 16 weeks.
Chang in World Health Organization Quality of Life Instruments (WHOQOL-BREF) from baseline to 16 weeks	This is a scale of quality of life. The range for total is 26-130. A higher score means a better outcome.	Baseline and 16 weeks.
Chang in Four-Meter Gait Speed from baseline to 16 weeks	Measured with seconds. A higher score means a worse outcome.	Baseline and 16 weeks.

Collaborators and Investigators

• Sponsor: Central Taiwan University of Science and Technology
• Investigators: Principal Investigator: Chiu, Central Taiwan University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Actual): August 22, 2023
• Primary Completion (Actual): August 30, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: September 7, 2022
• First Submitted That Met QC Criteria: February 8, 2023
• First Posted (Actual): February 9, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 9, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Sarcopenia
• Other Study ID Numbers: 202300020A3

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