Effects of a Multi-intervention Programme for the Elderly

Dementia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05720416
• Other study ID #: 202300020A3
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 22, 2023
• Est. completion date: December 2024

Study information

• Verified date: September 2023
• Source: Central Taiwan University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dementia
• Sarcopenia
• Sarcopenic Obesity

Intervention

Dietary Supplement:
• protein supplementation
protein supplementation for 16 weeks

Behavioral:
• muscle strength training
muscle strength training for 16 weeks

Other:
• usual care
no intervention

Locations

Country	Name	City	State
Taiwan	Daycare center at Central Taiwan University of Science and Technology	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
Central Taiwan University of Science and Technology

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Chang in weight of muscle and fat from baseline to 16 weeks	muscle mass(kg), fat mass (kg)	Baseline and 16 weeks
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Demographic attributes	Gender, education, age, married status, religion, medication, diseases, work and height.	Baseline
Primary	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
Primary	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.
Primary	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.
Primary	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.