The Impact of Exercise Intervention on Physical Function Falls, and Physical Restraint for Long-term Care Residents

NCT ID: NCT06096467

Last Updated: 2024-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2024-01-31

Brief Summary

The goal of this clinical trial is to test the effect of the Cross-disciplinary Teamwork Care Model and Exercise Intervention in residents living in long-term care institutions. The main question[s] it aims to answer are:

• Increased physical performance.
• Reduced the physical restraint.
• Reduced fall accidents.

Participants will accept the comprehension Exercise Intervention combined with protein supplementation or not.

Detailed Description

The prevalence of institutional physical restraint, both at home and abroad, remains alarmingly high. The Health Care Financing Administration (HCFA) in 1999 provided a comprehensive definition for physical restraint in nursing homes, encompassing any manual, physical, or mechanically related device, material, or tool attached to or installed on a resident's body that hinders their freedom of movement or contact with their body. The primary objective of implementing physical restraint in healthcare settings is to prevent patients from becoming agitated, safeguard them from self-inflicted injuries, protect the staff, prevent falls, and manage routine care and behavior control. Unfortunately, falls are a common occurrence among the elderly, whether they are living at home or in institutional settings.

Falls in the elderly are often attributed to a myriad of factors, including poor physical function and the use of multiple medications. Impaired physical function components such as diminished muscle strength, imbalanced balance abilities, delayed reaction times, postural hypotension, and cognitive dysfunction are frequently observed contributors to falls. Furthermore, malnutrition or undernutrition is a prevalent concern among the elderly, affecting those being cared for at home or placed in institutional settings. Malnutrition compounds the adverse effects on physical function, leading to muscular weakness and potentially the development of sarcopenia, a condition characterized by a loss of muscle mass and strength. This not only compromises immunity but also elevates the risk of disease and increases the likelihood of disability or falls among the elderly.

In response to these challenges, this study aims to be conducted collaboratively by the three private nursing type centers (Guang-nenn Care Center for the Elderly, Tung-shin Long-term Care Center, and the Hu-An Long-term Care Center for the Elderly). The study will involve 22 elderly patients. The primary objective is to address the multifaceted issues of physical restraint, falls, and declining physical function in elderly care facilities.

The research team began by conducting a systematic review of the existing literature on long-term care institutions, interdisciplinary teamwork care models, sports interventions, physical function, falls, and physical restraint. This comprehensive review served as the foundation for designing a 12-month "comprehensive multi-component exercise" program. The program is based on evidence from the literature and aims to enhance the strength, balance, and mobility of residents through carefully tailored exercise interventions.

The ultimate goal of the exercise program is to reduce the utilization of physical restraint as a means to prevent falls. By focusing on improving residents' physical abilities, the research anticipates a decrease in the need for physical restraint, ultimately enhancing the quality of life for elderly individuals in these long-term care facilities.

Conditions

Exercise Intervention; Protein Supplementation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Comprehension exercise training combined with protein supplementation (CET+PS)

CET+PS: the comprehension exercise training combined with protein supplementation

Group Type: EXPERIMENTAL

Comprehension Exercise Training

Intervention Type: BEHAVIORAL

Comprehension exercise: 45\~50 minutes exercise for each session(warm-up, resistive, functional activities and balance exercise, and cool-down)

Protein Supplement

Intervention Type: DIETARY_SUPPLEMENT

Protein Supplement: 40 g. whey protein for each serving and provided immediately after the CET session

Comprehension exercise training combined with placebo milk (CET+PC)

CET+PC: the comprehension exercise training combined with placebo milk

Group Type: PLACEBO_COMPARATOR

Comprehension Exercise Training

Intervention Type: BEHAVIORAL

Comprehension exercise: 45\~50 minutes exercise for each session(warm-up, resistive, functional activities and balance exercise, and cool-down)

Placebo milk

Intervention Type: DIETARY_SUPPLEMENT

Placebo milk: 8 g. protein for each serving and provided immediately after the CET session

Interventions

Comprehension Exercise Training

Comprehension exercise: 45\~50 minutes exercise for each session(warm-up, resistive, functional activities and balance exercise, and cool-down)

Intervention Type: BEHAVIORAL

Placebo milk

Placebo milk: 8 g. protein for each serving and provided immediately after the CET session

Intervention Type: DIETARY_SUPPLEMENT

Protein Supplement

Protein Supplement: 40 g. whey protein for each serving and provided immediately after the CET session

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

CET; PC; PS

Eligibility Criteria

Inclusion Criteria

1. Age is 65 years or older

2. Placement is greater than or equal to 6 months

3. Less dependency in activities of daily life (ADL) function50 (severe to moderate dependency, Barthel index: 21 ≤ score ≤ 90)

4. Able to understand the exercise instructions and follow the order.

Exclusion Criteria

1. Skeletomuscular (severe osteoarthritis (OA) or recent or mal- or non-union fracture, etc.) or cardiopulmonary diseases (COVID-19 or unstable angina or controlled hypertension, etc.) that are unstable and pose a threat to safety

2. Mental disorders that prevent the subject from following instructions (severe mental disorder, Short Portable Mental State Questionnaire (SPMSQ): 8 ≤ score ≤ 10).

3. Protein supplementations are contraindicated.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cardinal Tien Hospital

OTHER

Sponsor Role: lead

Responsible Party

Tsai Ren Jei, MS

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Senyeong Kao, Ph.D

Role: STUDY_CHAIR

National Defense Medical Center, School of Public Health

Locations

Cardinal Tein Hospital

New Taipei City, , Taiwan

Countries

Taiwan

References

Liao CD, Lee PH, Hsiao DJ, Huang SW, Tsauo JY, Chen HC, Liou TH. Effects of Protein Supplementation Combined with Exercise Intervention on Frailty Indices, Body Composition, and Physical Function in Frail Older Adults. Nutrients. 2018 Dec 4;10(12):1916. doi: 10.3390/nu10121916.

Reference Type: RESULT

PMID: 30518122 (View on PubMed)

Carlsson M, Littbrand H, Gustafson Y, Lundin-Olsson L, Lindelof N, Rosendahl E, Haglin L. Effects of high-intensity exercise and protein supplement on muscle mass in ADL dependent older people with and without malnutrition: a randomized controlled trial. J Nutr Health Aging. 2011 Aug;15(7):554-60. doi: 10.1007/s12603-011-0017-5.

Reference Type: RESULT

PMID: 21808934 (View on PubMed)

Other Identifiers

TSGHIRB SOP AF03-05.4/D6.0

Identifier Type: -

Identifier Source: org_study_id