Effects of a Multi-intervention Programme for the Elderly

NCT05720416 | Completed

• 1 other identifier: 202300020A3
• Study Type: interventional
• Target: 207
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcopenia; Sarcopenic Obesity; Dementia

Outcome Measures

Primary Outcomes (14)

• 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.

Study Arms (3)

muscle strength training and protein supplementation

EXPERIMENTAL

Dietary Supplement: protein supplementation; Behavioral: muscle strength training

usual care

PLACEBO COMPARATOR

Other: usual care

muscle strength training

EXPERIMENTAL

Behavioral: muscle strength training

Interventions

protein supplementation DIETARY_SUPPLEMENT

protein supplementation for 16 weeks

muscle strength training and protein supplementation

muscle strength training BEHAVIORAL

muscle strength training for 16 weeks

muscle strength training; muscle strength training and protein supplementation

usual care OTHER

no intervention

usual care

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Central Taiwan University of Science and Technology: lead

Study Sites (1)

Daycare center at Central Taiwan University of Science and Technology

Taichung, Taiwan

Location

MeSH Terms

Conditions

Sarcopenia; Dementia

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Brain Diseases; Central Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Chiu

  Central Taiwan University of Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor of nursing department

Study Record Dates

• First Submitted: September 7, 2022
• First Posted: February 9, 2023
• Study Start: August 22, 2023
• Primary Completion: August 30, 2024
• Study Completion: December 31, 2024
• Last Updated: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)