Effects of a Multi-intervention Programme on the Muscle Strength, Body Composition, Physical Performance and Quality of Life of the Elderly
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 207
- Locations
- 1
- Primary Endpoint
- Chang in Clinical Dementia Rating from baseline to 16 weeks
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
usual care
Intervention: usual care (Other)
muscle strength training
Intervention: muscle strength training (Behavioral)
muscle strength training and protein supplementation
Intervention: protein supplementation (Dietary Supplement)
muscle strength training and protein supplementation
Intervention: muscle strength training (Behavioral)
Outcomes
Primary Outcomes
Chang in Clinical Dementia Rating from baseline to 16 weeks
Time Frame: Baseline and 16 weeks
Mental Function Assessment. The range is 0-3. A Higher score means a worse outcome.
Chang in Cornell Scale for Depression in Dementia from baseline to 16 weeks
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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.
Demographic attributes
Time Frame: Baseline
Gender, education, age, married status, religion, medication, diseases, work and height.
Chang in PERSONAL WELLBEING INDEX from baseline to 16 weeks
Time Frame: 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
Time Frame: 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
Time Frame: Baseline and 16 weeks
muscle mass(kg), fat mass (kg)
Chang in Four-Meter Gait Speed from baseline to 16 weeks
Time Frame: Baseline and 16 weeks.
Measured with seconds. A higher score means a worse outcome.
Secondary Outcomes
No secondary outcomes reported
Investigators
Chiu Shu-Ching
assistant professor of nursing department
Central Taiwan University of Science and Technology