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Effects of a Multi-intervention Programme for the Elderly

Primary Purpose

Sarcopenia, Sarcopenic Obesity, Dementia

Status
Active
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
protein supplementation
muscle strength training
usual care
Sponsored by
Central Taiwan University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Sarcopenia

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Daycare center at Central Taiwan University of Science and Technology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

muscle strength training and protein supplementation

usual care

muscle strength training

Arm Description

Outcomes

Primary Outcome Measures

Chang in muscle strength from baseline to 16 weeks
pinch, grip and quadriceps strength. A Higher score means a better outcome.
Chang in weight of muscle and fat from baseline to 16 weeks
muscle mass(kg), fat mass (kg)
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.
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.
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.
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.
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.
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.
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.
Demographic attributes
Gender, education, age, married status, religion, medication, diseases, work and height.
Chang in PERSONAL WELLBEING INDEX from baseline to 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
The range for total is 0-70. A higher score means a better outcome.
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.
Chang in Four-Meter Gait Speed from baseline to 16 weeks
Measured with seconds. A higher score means a worse outcome.

Secondary Outcome Measures

Full Information

First Posted
September 7, 2022
Last Updated
September 4, 2023
Sponsor
Central Taiwan University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT05720416
Brief Title
Effects of a Multi-intervention Programme for the Elderly
Official Title
Effects of a Multi-intervention Programme on the Muscle Strength, Body Composition, Physical Performance and Quality of Life of the Elderly
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 22, 2023 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Central Taiwan University of Science and Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia, Sarcopenic Obesity, Dementia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
muscle strength training and protein supplementation
Arm Type
Experimental
Arm Title
usual care
Arm Type
Placebo Comparator
Arm Title
muscle strength training
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
protein supplementation
Intervention Description
protein supplementation for 16 weeks
Intervention Type
Behavioral
Intervention Name(s)
muscle strength training
Intervention Description
muscle strength training for 16 weeks
Intervention Type
Other
Intervention Name(s)
usual care
Intervention Description
no intervention
Primary Outcome Measure Information:
Title
Chang in muscle strength from baseline to 16 weeks
Description
pinch, grip and quadriceps strength. A Higher score means a better outcome.
Time Frame
Baseline and 16 weeks
Title
Chang in weight of muscle and fat from baseline to 16 weeks
Description
muscle mass(kg), fat mass (kg)
Time Frame
Baseline and 16 weeks
Title
Chang in Activities of Daily Living from baseline to 16 weeks
Description
This is a scale of physical function. The range for total score is 0-100. A Higher score means a worse outcome.
Time Frame
Baseline and 16 weeks
Title
Chang in Instrumental activities of daily living from baseline to 16 weeks
Description
This is a scale of physical function. The range for total score is 0-24. A Higher score means a better outcome.
Time Frame
Baseline and 16 weeks
Title
Chang in Clinical Dementia Rating from baseline to 16 weeks
Description
Mental Function Assessment. The range is 0-3. A Higher score means a worse outcome.
Time Frame
Baseline and 16 weeks
Title
Chang in Cornell Scale for Depression in Dementia from baseline to 16 weeks
Description
Mental Function Assessment. The range for total score is 0-38. A Higher score means a worse outcome.
Time Frame
Baseline and 16 weeks
Title
Chang in Cohen-Mansfield Agitation Inventory from baseline to 16 weeks
Description
This is a scale of behavior measurement. The range for total is 29-203. A higher score means a worse outcome.
Time Frame
Baseline and 16 weeks
Title
Chang in EQ5D from baseline to 16 weeks
Description
This is a scale of quality of life. The range for total is 0-20. A higher score means a worse outcome.
Time Frame
Baseline and 16 weeks
Title
Chang in QUALIDEM from baseline to 16 weeks
Description
The scale is a dementia-specific Qol instrument. The range for total score is 0-120. A higher score means a better outcome.
Time Frame
Baseline and 16 weeks
Title
Demographic attributes
Description
Gender, education, age, married status, religion, medication, diseases, work and height.
Time Frame
Baseline
Title
Chang in PERSONAL WELLBEING INDEX from baseline to 16 weeks
Description
The range for total is 0-80. A higher score means a better outcome.
Time Frame
Baseline and 16 weeks
Title
Chang in PERSONAL WELLBEING INDEX intellectual disability from baseline to 16 weeks
Description
The range for total is 0-70. A higher score means a better outcome.
Time Frame
Baseline and 16 weeks.
Title
Chang in World Health Organization Quality of Life Instruments (WHOQOL-BREF) from baseline to 16 weeks
Description
This is a scale of quality of life. The range for total is 26-130. A higher score means a better outcome.
Time Frame
Baseline and 16 weeks.
Title
Chang in Four-Meter Gait Speed from baseline to 16 weeks
Description
Measured with seconds. A higher score means a worse outcome.
Time Frame
Baseline and 16 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chiu
Organizational Affiliation
Central Taiwan University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Daycare center at Central Taiwan University of Science and Technology
City
Taichung
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of a Multi-intervention Programme for the Elderly

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