A Dyadic e-Health System on Enhancing Healthy Lifestyles of Older Adults With Sarcopenia

NCT06088511 | Not Yet Recruiting

• 1 other identifier: HSEARS20230817002
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

Sarcopenia is defined as a reduction in muscle mass, muscle strength, and physical performance. Without proper management, sarcopenia may result in adverse health outcomes. Continuously maintain healthy lifestyle, such as being physically active, taking adequate protein in daily diet, are effective in preventing and managing sarcopenia. e-Health has been used successfully to translate evidence-based lifestyle interventions into daily practice by enhancing self-awareness, promoting self-monitor and sustaining self-management for other populations with different health problems. This project aims to develop, implement and evaluate the preliminary effects of an e-Health System to encourage older adults with sarcopenia to maintain healthy lifestyles (i.e. regular exercise and adequate intake of high-quality protein). Combining the concepts of smart health, the System aims to enhance users' self-monitoring (Level 1) and self-management (Level 2) of sarcopenia. Level 1 aims to enhance participants' and their family members' awareness of the risks of sarcopenia through continued monitoring. The System will perform baseline and regular subjective (such as self-administered questionnaires) and objective (such as activity levels by an embedded accelerometer) assessments on the participants. The embedded risk calculator in the System will analyze the scores obtained from different assessments and then recommend participants to follow the healthy lifestyle interventions in Level 2. Level 2 aims to enhance participants' and their family members' ability to manage the health problems related sarcopenia. The System will recommend two major evidence-based lifestyle interventions, including physical exercise and nutritional advice, based on the analysis of the assessment data in Level 1. These interventions will be conducted during the four face-to-face sessions and continuously self-practised at home. The interventions will provide interactive, immediate feedback to the participants and their family members to improve their involvement. The participants and their family members can monitor their progress via the System. The investigators hypothesize that the experimental group who has adopted the e-Health system in their daily life to manage sarcopenia will exhibit milder symptoms of sarcopenia and more sustainable self-management ability than participants in the control group who has received usual care.

Conditions

Sarcopenia

Keywords

Sarcopenic Obesity; e-Health System; Family-oriented Nutritional Intervention; Exercise; RCT

Outcome Measures

Primary Outcomes (6)

• Changes of muscle strength

  Handgrip strength (kg) will be measured by using the hand dynamometer.

  Change from baseline to 4 weeks immediately after the completion of all supervised sessions, 12 weeks after the completion of the self-management phase

• Changes of muscle mass

  Muscle mass (kg) will be measured by using bioelectrical impedance analysis.

  Change from baseline to 4 weeks immediately after the completion of all supervised sessions, 12 weeks after the completion of the self-management phase

• Changes of body mass index

  The weight and height will be combined to report BMI in kg/m\^2.

  Change from baseline to 4 weeks immediately after the completion of all supervised sessions, 12 weeks after the completion of the self-management phase

• Changes of waist circumference

  Waist circumference was taken as the minimum circumference between the umbilicus and xiphoid process and measured to the nearest 0.5 cm.

  Change from baseline to 4 weeks immediately after the completion of all supervised sessions, 12 weeks after the completion of the self-management phase

• Changes of fat mass

  Fat mass (kg) will be measured by using bioelectrical impedance analysis.

  Change from baseline to 4 weeks immediately after the completion of all supervised sessions, 12 weeks after the completion of the self-management phase

• The Short Physical Performance Battery (SPPB) scale

  The Short Physical Performance Battery (SPPB) scale will be used to measure physical function, which is a well-established tool for monitoring function in older people, which contains three kinds of assessments: stand for 10 seconds with feet in 3 different positions, 3-meter or 4-meter walking speed test, and time to rise from a chair for five times. The scores of SPPB range from 0 (worst performance) to 12 (best performance). The minimum and maximum values are 0 and 10 respectively. Higher scores mean a better performance.

  Change from baseline to 4 weeks immediately after the completion of all supervised sessions, 12 weeks after the completion of the self-management phase

Secondary Outcomes (12)

• Mini Nutritional Assessment (MNA) Short-form

  Change from baseline to 4 weeks immediately after the completion of all supervised sessions, 12 weeks after the completion of the self-management phase

• Health Action Process Approach (HAPA) Nutrition Self-efficacy Scale

  Change from baseline to 4 weeks immediately after the completion of all supervised sessions, 12 weeks after the completion of the self-management phase

• Dietary quality index-International (DQI-I)

  Change from baseline to 4 weeks immediately after the completion of all supervised sessions, 12 weeks after the completion of the self-management phase

• Diet Adherence

  Change from baseline to 4 weeks immediately after the completion of all supervised sessions, 12 weeks after the completion of the self-management phase

• Exercise Adherence

  Change from baseline to 4 weeks immediately after the completion of all supervised sessions, 12 weeks after the completion of the self-management phase

Study Arms (2)

The Experimental Group

EXPERIMENTAL

Participants in the Experimental Group will attend an implementation program guided by the Self-Determination Theory (SDT). The 12-week intervention consists of a 4-week, group-based, face-to-face supervised sessions conducted by a well-trained Research Assistant, plus an 8-week self-management phase.

Behavioral: e-Health System with nutritional advice; Behavioral: The Exercise Training

The Control Group

NO INTERVENTION

Participants in The Control Group will attend 4-weekly, group-based, regular face-to-face health talks about managing sarcopenia with the exact dosage provided to the intervention group.

Interventions

e-Health System with nutritional advice BEHAVIORAL

A 12-week intervention consisting of a 4-weekly group-based, face-to-face supervised sessions, and an 8-week self-management phase will be arranged to the experimental group. The features of the System will be introduced to the users and their family members in the first two face-to-face sessions. The users and their family members will then be able to start using the System with the mobile app. In the other two sessions, all participants in the experimental group will learn how to accurately complete their dietary records in the e-Health System and will be provided with nutritional advice. For the 8-week self-management phase, the participants will be recommended to follow the lifestyle interventions to relieve their problems related to sarcopenia. The participants are required to fill in their dietary record in the e-Health System every day, and will be provided with nutritional advice to improve high-quality protein and leucine intake, which is essential for muscle building.

The Experimental Group

The Exercise Training BEHAVIORAL

For the 8-week self-management phase, the participants will be recommended to follow the lifestyle interventions to relieve their problems related to sarcopenia. The participants in the experimental group will also be suggested to continually practise exercise training at home for 30 minutes at least 5 times per week. Participants can review the self-learning exercise videos embedded in the System. The exercise trainings include: a) progressive resistance training to improve muscle strength; and b) brisk walking exercise to maintain walkability.

The Experimental Group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Community-dwelling older people aged \> 60 years;
• Meeting the diagnostic criteria of sarcopenia according to the Asian Sarcopenia Working Group (ASWG):
• Early-stage sarcopenia refers to the fulfillment of one of the following criteria: low handgrip strength \< 28 kg for men and \< 18 kg for women, low muscle quality as reflected by low appendicular skeletal muscle mass (ASM) /height squared \< 7 kg/m2 for men and \<5.7 kg/m2 for women, or low physical performance with a Short Physical Performance Battery (SPPB) score of \< 9;
• Able to communicate, read, and write in Chinese without significant hearing and vision problems to ensure that our instructions are understood;
• Own a smartphone, and able to access the internet at home or elsewhere;
• Reside with family and have at least one daily shared meal (family is defined as an individual who has a significant personal relationship with the participant, such as next of kin, spouse and the individual must be at aged \> 18); and
• Able to identify a family member who has a smartphone and is willing to support the participant to use the e-Health System.

You may not qualify if:

• With any form of disease or condition that might affect food intake and digestion (such as severe heart or lung diseases, diabetes, cancer, or autoimmune diseases);
• Currently suffering from acute gouty arthritis or had a gout attack in the past year;
• Taking medications that may influence eating behaviour, digestion, or metabolism (such as weight loss medication);
• Being addicted to alcohol, which might affect the effort to change dietary behaviour;
• Having impaired mobility, which might affect participation in exercise training, as defined by a modified Functional Ambulatory Classification score of \< 7;
• Having renal impairment, based on the renal function blood test which will be screened by a geriatrician;
• Having depressive symptomatology, defined by a Geriatric Depression Scale score of \> 8;
• Suffering from dementia (i.e., MoCA\<20 or clinical dementia rating ≥1);
• Having any medical implant device such as a pacemaker, because low-level currents will flow through the body when doing the bioelectric impedance analysis (BIA by InBody S10, Korea), which may cause the device to malfunction.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

The Hong Kong Polytechnic Universtiy

Hong Kong, Hong Kong

Location

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Related Links

• Ergonomics of human-system interaction - Part 11: Usability: Definitions and concepts

MeSH Terms

Conditions

Sarcopenia; Motor Activity

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Behavior

Study Officials

• Justina Liu, PhD

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Justina Liu, PhD

CONTACT

27666427; justina.liu@polyu.edu.hk

Amy Cheung, MA

CONTACT

27666763; amy-ka-po.cheung@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The researchers who perform the outcome assessment and analysis will be blinded to the group allocations of participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A two-arm, assessor-blinded, parallel design randomized control trial (RCT) consisting of an experimental and a control group will be adopted to evaluate the effectiveness of a e-Health System delivered in a dyadic approach to encourage older adults with sarcopenia to maintain healthy lifestyles.

Study Record Dates

• First Submitted: October 12, 2023
• First Posted: October 18, 2023
• Study Start: May 6, 2024
• Primary Completion: June 30, 2025
• Study Completion: January 1, 2026
• Last Updated: March 22, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)