Effects of a Multi-intervention Programme for the Elderly

Study Overview
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Brief Summary
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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.

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

Conditions
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Sarcopenia, Sarcopenic Obesity, Dementia

Intervention / Treatment
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* Dietary Supplement: protein supplementation
* Behavioral: muscle strength training
* Other: usual care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: muscle strength training and protein supplementation<br> | Dietary Supplement: protein supplementation<br>* protein supplementation for 16 weeks<br>Behavioral: muscle strength training<br>* muscle strength training for 16 weeks<br>|
| Placebo Comparator: usual care<br> | Other: usual care<br>* no intervention<br>|
| Experimental: muscle strength training<br> | Behavioral: muscle strength training<br>* muscle strength training for 16 weeks<br>|

What is the study measuring?
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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. |