An interventional study of e-Health System with nutritional advice and The Exercise Training in Sarcopenia, sponsored by The Hong Kong Polytechnic University. Not yet recruiting at 1 site in Hong Kong. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2024-03-22.
Sponsored by The Hong Kong Polytechnic University · Not applicable, Interventional, and Treatment
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.
Sarcopenia is defined as a reduction in appendicular skeletal muscle mass, muscle strength, and physical performance. The prevalence of sarcopenia is high, and it appears in about 25% of local older adults. Without proper management, sarcopenia may result in adverse health outcomes leading to poor quality of life and premature institutionalization. It also causes a burden on their family members. The current evidence shows that preventing and managing sarcopenia with healthy lifestyle interventions, which include maintaining a physically active lifestyle, ideal body weight, adequate protein intake and social participation, tend to produce positive outcomes if older adults can continuously maintain these healthy lifestyles.
e-Health was defined as "the cost-effective and secure use of information and communications technologies in support of health". 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 addressing obesity in young people, smoking cessation in adults and promoting physical activities in older adults with sedentary lifestyle. For example, a systematic review of 15 papers with 1967 participants compared the e-Health based interventions with the control groups to reduce sedentary behaviour and increase physical activity levels. The results showed that the group that received e-Health based interventions had a significantly increased level of physical activity compared with the control groups.
Despite all these potential benefits of using e-Health to manage health, studies indicated that older adults tend to be reluctant to use new technologies due to the inability to integrate them into their daily lives. Consequently, it has been posited that older adults may be less capable or willing to adopt e-Health strategies to manage their health. One possible explanation for this low adaptation rate is that older adults cannot integrate the technologies into their daily lives. Studies have argued that the motivation of participants to sustain the use of the new technologies depends on the extent to which the participants feel that the technologies can fulfil their needs, align with their goals, and meet their expectations. In addition, older adults often attempt to adopt new habits, such as using a new electronic device, maintaining a physically active lifestyle, while being embedded in social networks comprising, amongst others, friends and family. However, current e-Health-based interventions are usually focused on individuals. Given that empirical evidence highlights the role of family members in influencing older adults' behaviour, including an adaptation of technologies and healthy lifestyles, there is a need to consider the potential benefits of involving family support when delivering an e-Health based intervention to older adults.
The World Health Organization's global strategy for digital health emphasizes the importance of empowering older adults to integrate technology into their daily life. Family members who have a close relationship with older adults can support them in adopting the e-Health based interventions for self-management of the health problems. Dyads are defined as two individuals (such as, family caregiver and care recipient) maintaining a socially close relationship. There has been some evidence suggesting that e-Health based interventions targeting the promotion of psychosocial wellbeing through a dyadic approach benefit both care recipients and caregivers. However, most positive findings were from studies targeting children/adolescent-parents dyads or young adult dyads. In addition, behavioural change (such as adopting a new healthy diet habit) is interdependent between care recipients and family caregivers. With the support of family, older adults can easily familiarise themselves with the technical design and functions of the e-Health platform, overcome barriers to adopting the technology and sustain healthy lifestyles in their daily routine. Through the dyadic approach, family members may co-develop an action plan to target the health goals, receive personalized feedback on participants' performance and obtain encouragement from the family members via the e-health platform. Family support may facilitate and motivate older adults (participants) to continue using the e-Health platform and sustain healthy lifestyles. Promising evidence suggests that dyadic interventions can deliver synergistic benefits to both family caregivers and care recipients. However, a limited empirical study has adopted a dyadic approach for older adults to use e-Health platforms to enhance their healthy lifestyles for managing sarcopenia.
Aims and objectives
An e-Health system which comprises of the concept of smart health (i.e. refer to individual demographic and health data) will be developed. This project aims to evaluate the effectiveness of an e-Health System delivered in a dyadic approach to encourage older adults with sarcopenia to maintain healthy lifestyles (i.e. adequate intake of high-quality protein and regular exercises). Two objectives of this study include:
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, better mobility and physical function and better quantity and quality of protein intake, greater self-efficacy and more sustainable self-management ability than participants in the control group who has received usual care.
1,208 studies on the registry are indexed under Sarcopenia; 402 are open to participants now.
This study's planned enrollment of 88 is above the median of 60 across 775 interventional studies indexed under Sarcopenia.
Browse Sarcopenia studies →The Hong Kong Polytechnic University is the lead sponsor of 659 studies on the registry; 250 are open to participants now.
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Exclusion Criteria:
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
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.
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.
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.
Changes of muscle strength
Handgrip strength (kg) will be measured by using the hand dynamometer.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Change from baseline to 4 weeks immediately after the completion of all supervised sessions, 12 weeks after the completion of the self-management phase
Mini Nutritional Assessment (MNA) Short-form
Participants' nutritional status will be assessed through the Mini Nutritional Assessment (MNA). It is a simple and quick tool for assessing older people who are malnourished or at risk of malnutrition. The MNA Short-form contains 6 items. Questions are weighted, 2-3 points per item. Scores are categorised as 0-7 (malnourished), 8-11 (at risk of malnutrition), 12-14 (normal nutritional status). The minimum and maximum values are 0 and 14 respectively. Higher scores mean a better nutritional status.
Time frame: 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
The nutrition self-efficacy scale is one part of the Health-Specific Self-efficacy Scale which was developed by Ralf Schwarzer and Britta Renner. The nutritional self-efficacy scale is a 5-item scale, and each item is rated on 4-point likert scale from 1= very uncertain, 2=rather uncertain, 3=rather certain, 4=very certain. Higher score means higher self-efficacy. The minimum and maximum values are 0 and 20 respectively. Higher scores mean a higher self-efficacy.
Time frame: 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)
The DQI-I will be used to estimate the dietary quality of participants. It is a well-used questionnaire without being affected by culture. The total scores range from 0 to 100, with a higher score representing better diet quality. The minimum and maximum values are 0 and 100 respectively .Higher scores mean a better diet quality.
Time frame: 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
The adherence to protein intake will be reflected by the protein score in the DQI-I. Total calorie intake will be analyzed by a software program "Food Processor®". If any participant forgets to keep the dietary record, the 7-day food recall method will be used by the experimental group facilitator to check the participant's food intake, an approach commonly used in nutritional studies. The participants' attendance rate in the consultation sessions will be monitored.
Time frame: 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
Assessed based on the participants' attendance in the weekly exercise training session, as well as on their self-reports on their overall adherence to the exercise regimen.
Time frame: 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 Numeric Rating Scale (NRS)
The Numeric Pain Scale (NRS) is a self-reported questionnaire consists of 1 question measuring pain intensity. The scores range from 0 to 10, with higher scores indicate greater pain. A cutoff value \> 3 indicates greater pain.
Time frame: 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 Brief Fatigue Inventory (BFI)
The Brief Fatigue Inventory (BFI) measures nine items on 10-point numeric scales for fatigue level and interference with daily life. A global fatigue score can be obtained by averaging all the items on the BFI. The total scores range from 0-10 points, with higher scores indicate greater fatigue. A cutoff value ≥ 4 on the BFI scale indicates intervention for fatigue.
Time frame: 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 Chinese Self-Efficacy for Exercise (CSEE) scale
The CSEE scale contains of 9 items. Each item is rated on 11-point Liker scale from 0 = no confidence to 10 = full of confidence. All item scores are summed to get the total score which ranges from 0 to 90 with a higher score indicates higher exercise self-efficacy.
Time frame: 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 Fried Frailty Index (FFI)
Fried Frailty Index includes: i) an unintentional loss of 10% of body weight in the past year; ii) exhaustion: by answering 'Yes' to either 'I felt that everything I did was an effort', or 'I could not get going in the last week'; iii) a slow walk time: with an average walking speed in the lowest quintile stratified by median body height; iv) reduced handgrip strength: with maximal grip strength in the lowest quintile stratified by body mass index quartile; and v) the Physical Activity Scale for the Elderly-Chinese (PASE-C) score in the lowest quintile (i.e., \< 30 for men and \< 27.7 for women).
Time frame: 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 the 15-item Chinese version Geriatric Depression Scale (C-GDS)
The C-GDS consists of 15 yes/no questions. Each negative answer will be given 1 point, with possible scores ranging from 0-15. The higher score indicates more depressive mood. • Respondents with a score more than 8 are identified as having symptoms of depression.
Time frame: 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 the Chinese (Hong Kong) 12-item Short Form Health Survey (SF-12v2)
The Chinese (Hong Kong) 12-item SF-12v2 is a shortened form (12 items) of the SF-36v2 Health Survey. This is a generic assessment of health-related quality of life (HR QOL) from the participants' perspective. It consists of 12 questions measuring eight domains of health, including physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. These health domain scores are aggregated into the physical component summary (PCS) score and the mental component summary (MCS) score. Eight domains of SF-12v2 (HK) are measured on a scale ranging from 0 to 100. A higher domain score indicates a better HRQoL.
Time frame: 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 the Strength, Assistance in walking, Rise from a chair, Climb stairs, and Falls (SARC-F)
SARC-F includes five components: strength, assistance walking, rise from a chair, climb stairs, and falls. SARC-F items are selected to reflect health status changes associated with the consequences of sarcopenia. The scores range from 0 to 10, with 0 to 2 points for each component. A score equal to or greater than 4 is predictive of sarcopenia and poor outcome.
Time frame: Change from baseline to 4 weeks immediately after the completion of all supervised sessions, 12 weeks after the completion of the self-management phase
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Plan to share: No — For confidentiality, the data will be kept anonymous and the information of all participants will be replaced by reference codes. The data collected will be kept in a locked place and electronic versions will be encrypted, and only be accessible by the researchers. All data will be destroyed within 7 years after the completion of this research.
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The Hong Kong Polytechnic University