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

NCT06096467 | Completed DMC

• 1 other identifier: TSGHIRB SOP AF03-05.4/D6.0
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Exercise Intervention; Protein Supplementation

Keywords

protein supplementation; exercise; long-term care institutions

Outcome Measures

Primary Outcomes (1)

• Short Physical Performance Battery (SPPB)

  To evaluate the physical functional performance of elderly individuals.The assessment primarily comprises three components: standing balance, mobility (four-meter walk test), and muscle strength (five-repetition sit-to-stand test).

  T1: before Phase 1 intervention; T2: immediately after Phase 1 intervention; T3: before Phase 2 intervention; T2: immediately after Phase 2 intervention, and completed the assessments within 1 week.

Secondary Outcomes (4)

• Muscle strength of Upper limb and lower limb

  T1: before Phase 1 intervention; T2: immediately after Phase 1 intervention; T3: before Phase 2 intervention; T4: immediately after Phase 2 intervention, and completed the assessments within 1 week.

• Functional forward reach (FFR)

  T1: before Phase 1 intervention; T2: immediately after Phase 1 intervention; T3: before Phase 2 intervention; T4: immediately after Phase 2 intervention, and completed the assessments within 1 week.

• Number of fall occurrences

  T1: before Phase 1 intervention; T2: immediately after Phase 1 intervention; T3: before Phase 2 intervention; T4: immediately after Phase 2 intervention, and completed the assessments within 1 week.

• Number of physical restraint occurrence

  T1: before Phase 1 intervention; T2: immediately after Phase 1 intervention; T3: before Phase 2 intervention; T4: immediately after Phase 2 intervention, and completed the assessments within 1 week.

Study Arms (2)

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

EXPERIMENTAL

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

Behavioral: Comprehension Exercise Training; Dietary Supplement: Protein Supplement

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

PLACEBO COMPARATOR

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

Behavioral: Comprehension Exercise Training; Dietary Supplement: Placebo milk

Interventions

Comprehension Exercise Training BEHAVIORAL

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

Also known as: CET

Comprehension exercise training combined with placebo milk (CET+PC); Comprehension exercise training combined with protein supplementation (CET+PS)

Placebo milk DIETARY_SUPPLEMENT

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

Also known as: PC

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

Protein Supplement DIETARY_SUPPLEMENT

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

Also known as: PS

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

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age is 65 years or older
• Placement is greater than or equal to 6 months
• Less dependency in activities of daily life (ADL) function50 (severe to moderate dependency, Barthel index: 21 ≤ score ≤ 90)
• Able to understand the exercise instructions and follow the order.

You may not qualify if:

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

Sponsors & Collaborators

• Cardinal Tien Hospital: lead

Study Sites (1)

Cardinal Tein Hospital

New Taipei City, 231, Taiwan

Location

Related Publications (2)

• 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.

  PMID: 30518122 RESULT

• 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.

  PMID: 21808934 RESULT

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Senyeong Kao, Ph.D

  National Defense Medical Center, School of Public Health

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 18, 2023
• First Posted: October 23, 2023
• Study Start: January 1, 2020
• Primary Completion: December 31, 2023
• Study Completion: January 31, 2024
• Last Updated: February 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)