- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04216056
Evaluation of a Frailty Intervention Program in Hong Kong
Evaluation of a Frailty Intervention Program in Hong Kong: A Pre-Post Study and a Focus Group Study
The present study aims to compare the pre-post effect of a frailty intervention program with exercise, nutrition, cognitive and social components with a control group without such program on improving gait speed and frailty in community-dwelling Chinese adults aged 50 and above who are pre-frail or frail using the FRAIL scale, and to obtain their views towards the frailty intervention program. The investigators hypothesized that the frailty intervention program will result in improvements regarding frailty, mobility, weight status and other health outcomes.
This study will be a non-randomized controlled study using a controlled before-and-after study design. Eligible subjects will be assigned to one of the two groups: frailty intervention program, or control group without any intervention, over 12 weeks. A total of 152 subjects (76 per group) will be recruited. A sub-sample of 25 subjects from the intervention group will be invited to share their experience and opinion in focus groups.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
A 30-month trial, which will be divided into three phases, namely study preparation and subject recruitment (6 months), data collection (18 months), and data entry and analysis (6 months), will be conducted.
This study will be a non-randomized controlled study using a controlled before-and-after study design. Eligible subjects will receive a baseline assessment in the community facilities. After that, eligible subjects will be assigned to one of the two groups: frailty intervention program, or control group without any intervention, over 12 weeks. Subjects in the frailty intervention program will be invited to participate in the following components: exercise, game training and nutrition education; while subjects in the control group will be asked to maintain their usual diet and physical activity patterns. A total of 152 subjects (76 per group) will be recruited. Outcome measurements will be collected at two time points, namely baseline (T0), and 12 (T1) weeks.
The primary outcome will be the improvement in gait speed over 12 weeks. Secondary outcomes will include the change in the following parameters over 12 weeks: frailty, handgrip strength, 5 chair stands, balance test, Frontal Assessment Battery, dietary intake, nutritional status, physical activity, self-rated health, life satisfaction and self-efficacy of chronic disease management. In a sub-sample of 25 subjects from the intervention group, their views towards the frailty intervention program will be obtained from the focus group study.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Hong Kong, China
- Chinese University of Hong Kong
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- People aged 50 years or older;
- FRAIL score ≥ 1, and thus are considered pre-frail / frail;
- Chinese origin;
- Normally reside in Hong Kong;
- Could speak and understand Chinese;
- Willing to follow the study procedures.
Exclusion Criteria:
- Live in a residential aged care facility;
- Recent (i.e. past 3 months) or concurrent participation in any clinical trial or exercise and/or cognitive and/or dietary intervention program;
- With medical advice or conditions prohibiting exercise or medical conditions that precluded safe participation in an exercise program;
- With any other indication of a major medical or psychological illness, as judged by the investigators as ineligible to participate the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Frailty intervention program
There will be 2 sessions per week for 12 weeks.
Each session includes 1 hour exercise (including 5-10 minute warm-up and cool-down routine, 20-30 minute chair-based resistance exercises using Thera-Bands for muscle groups in both the upper and lower body, and 20-30 minutes aerobic exercises); and 1 hour game training using computer video games, board games and card games.
Nutrition education will be given to the subjects based on their weight status.
The 1st level of nutrition information (healthy eating tips for frailty prevention and management) will be given to all subjects on regular basis during the 12-week study period via short videos, text messages or Whatsapp reminders.
On top of the 1st level nutrition information, 3 nutrition heath talks (1-1.5 hours per talk) about weight management will be given to those with BMI >=25 kg/m2, and/or waist circumference >=90 cm (male) or >=80 cm (female) during the 12-week study period.
|
There will be 2 sessions per week for 12 weeks.
Each session includes 1 hour exercise (including 5-10 minute warm-up and cool-down routine, 20-30 minute chair-based resistance exercises using Thera-Bands for muscle groups in both the upper and lower body, and 20-30 minutes aerobic exercises); and 1 hour game training using computer video games, board games and card games.
Nutrition education will be given to the subjects based on their weight status.
The 1st level of nutrition information (healthy eating tips for frailty prevention and management) will be given to all subjects on regular basis during the 12-week study period via short videos, text messages or Whatsapp reminders.
On top of the 1st level nutrition information, 3 nutrition heath talks (1-1.5 hours per talk) about weight management will be given to those with BMI >=25 kg/m2, and/or waist circumference >=90 cm (male) or >=80 cm (female) during the 12-week study period.
|
No Intervention: Control group
Subjects in the control group will be asked to maintain their usual diet and physical activity patterns over the 12 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in gait speed
Time Frame: baseline, 12 weeks
|
This outcome will be measured using the 6-meter walk test.
|
baseline, 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Frailty status
Time Frame: baseline, 12 weeks
|
Frailty status (i.e.
robust, prefrail or frail) measured using the frailty scale (FRAIL) in which unabbreviated scale name is unavailable for this scale.
Frailty scores from 0 to 5 (i.e., 1 point for each component; 0 = best to 5 = worst) and represent robust (0), pre-frail (1-2), and frail (3-5) health status.
|
baseline, 12 weeks
|
Handgrip strength
Time Frame: baseline, 12 weeks
|
Handgrip strength will be measured using a dynamometer.
|
baseline, 12 weeks
|
5 chair stands
Time Frame: baseline, 12 weeks
|
Muscle endurance in the lower extremities - Participant will be required to rise from a chair a total of 5 times, as quickly as they could, with arms across their chest.
The amount of time required to complete all 5 repetitions will be recorded.
|
baseline, 12 weeks
|
Balance test
Time Frame: baseline, 12 weeks
|
Participant will be required to stand with different postures and maintain balance for 10 seconds each.
The number of completed posture will be used for analysis.
|
baseline, 12 weeks
|
Cognitive performance
Time Frame: baseline, 12 weeks
|
Frontal Assessment Battery will be used to assess executive function.
Total score is a maximum of 18, higher scores indicating better performance.
|
baseline, 12 weeks
|
Dietary intake
Time Frame: baseline, 12 weeks
|
Dietary habits and patterns over the past week will be assessed using a questionnaire designed by the research team based on the questionnaire used in the Hong Kong Child Health Survey (Department of Health, 2009) with modifications.
|
baseline, 12 weeks
|
Nutritional status
Time Frame: baseline, 12 weeks
|
This outcome will be assessed using Mini-Nutritional Assessment Short Form (MNA-SF).
The total score of the MNA-SF ranges from 0-14 points, with 0-7 points indicate malnourished, 8-11 points as at risk of malnutrition and 12-14 points as normal nutritional status.
|
baseline, 12 weeks
|
Physical activity
Time Frame: baseline, 12 weeks
|
This outcome will be assessed using a validated Chinese version of the International Physical Activity Questionnaire (IPAQ-C).
Metabolic equivalent for Task (MET)-minutes/week values for walking, moderate-intensity activities, vigorous-intensity activities, and total physical activities will be calculated for data analysis.
Higher MET-minutes/week value represents higher amount of energy expended in carrying out physical activity.
|
baseline, 12 weeks
|
Self-rated health
Time Frame: baseline, 12 weeks
|
This outcome will be elicited by a single question, "Generally speaking, how is your health: excellent, very good, good, fair, or poor?" .
|
baseline, 12 weeks
|
Life satisfaction
Time Frame: baseline, 12 weeks
|
This outcome will be assessed by the subjects' response to the question "Are you satisfied with life?", using a 0 to 10-point linear scale.
Higher point represents better self-rated life satisfaction.
|
baseline, 12 weeks
|
Self-efficacy of chronic disease management
Time Frame: baseline, 12 weeks
|
This outcome will be assessed using a validated Chinese version of short-form Chronic Disease Self-Efficacy Scales (CDSES) for older adults.
Each item will be rated by the subjects on a scale from 1-10.
The total score of the short-form CDSES is the mean of the six items, with higher score indicates better self-efficacy.
|
baseline, 12 weeks
|
Views towards the frailty intervention program
Time Frame: 12 weeks
|
Participants in the intervention group will be invited to share their experience and opinion in focus groups (of 1 to 1.5 hours duration).
|
12 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Weight
Time Frame: baseline, 12 weeks
|
Weight in kilogram measured using standardized method.
|
baseline, 12 weeks
|
Height
Time Frame: baseline, 12 weeks
|
Height in centimeter measured using standardized method.
|
baseline, 12 weeks
|
Waist circumference
Time Frame: baseline, 12 weeks
|
Waist circumference in centimeter measured using standardized method.
|
baseline, 12 weeks
|
Systolic blood pressure
Time Frame: baseline, 12 weeks
|
Systolic blood pressure in mmHg measured using standardized method.
|
baseline, 12 weeks
|
Diastolic blood pressure
Time Frame: baseline, 12 weeks
|
Diastolic blood pressure in mmHg measured using standardized method.
|
baseline, 12 weeks
|
Fat mass percentage
Time Frame: baseline, 12 weeks
|
This outcome will be measured using bioelectrical impedance analysis (BIA).
|
baseline, 12 weeks
|
Fat free mass percentage
Time Frame: baseline, 12 weeks
|
This outcome will be measured using bioelectrical impedance analysis (BIA).
|
baseline, 12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jean Woo, MD, Chinese University of Hong Kong
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019.455
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Frailty
-
University of PennsylvaniaCompleted
-
Instituto Tecnologico y de Estudios Superiores...Not yet recruiting
-
Longeveron Inc.CompletedAging FrailtyUnited States
-
Longeveron Inc.CompletedAging FrailtyUnited States
-
The Hong Kong Polytechnic UniversityCompleted
-
Xijing HospitalUnknownFrailty SyndromeChina
-
Region ZealandUniversity of Southern DenmarkActive, not recruitingFrailty SyndromeDenmark
-
Neurological Associates of West Los AngelesEnrolling by invitation
-
IRCCS Centro San Giovanni di Dio FatebenefratelliCompleted
-
University of Erlangen-Nürnberg Medical SchoolCompleted
Clinical Trials on Frailty intervention program
-
Wayne State UniversityMichigan Health Endowment FundCompletedFrail Elderly SyndromeUnited States
-
Hospital Universitario GetafeKarolinska Institutet; Medical University of Lodz; Universidad Politecnica de... and other collaboratorsUnknownFrail Elderly Syndrome | Frailty | Frailty SyndromePoland, Spain, Sweden
-
Istanbul University - Cerrahpasa (IUC)UnknownFrailty | Frailty Syndrome | Salutogenesis | Sense of Coherence
-
Chang Gung Memorial HospitalRecruiting
-
Universiti Putra MalaysiaCompleted
-
Chang Gung Memorial HospitalMinistry of Health and Welfare, TaiwanRecruiting
-
University of ValenciaCompleted
-
Jordi Gol i Gurina FoundationCarlos III Health InstituteCompletedCognitive Impairment | Frail Elderly | DependenceSpain
-
VA Office of Research and DevelopmentEnrolling by invitationFrailtyUnited States
-
Diskapi Yildirim Beyazit Education and Research...Recruiting