Effects of a Multi-intervention Programme for the Elderly

Not Applicable

Completed

• Conditions: Sarcopenia; Sarcopenic Obesity; Dementia
• Interventions: Dietary Supplement: protein supplementation; Other: usual care; Behavioral: muscle strength training

• Registration Number: NCT05720416
• Lead Sponsor: Central Taiwan University of Science and Technology

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-07
• Study First Submitted QC: 2023-02-08
• Study First Posted: 2023-02-09
• Study Start: 2023-08-22
• Primary Completion: 2024-08-30
• Study Completion: 2024-12-31
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-09
• Last Update Posted: 2025-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 207

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
muscle strength training and protein supplementation	muscle strength training	-
muscle strength training	muscle strength training	-
muscle strength training and protein supplementation	protein supplementation	-
usual care	usual care	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

Daycare center at Central Taiwan University of Science and Technology; 🇨🇳 Taichung, Taiwan