Evaluation of a Frailty Intervention Program in Hong Kong

Frailty Clinical Trial

Official title:

Evaluation of a Frailty Intervention Program in Hong Kong: A Pre-Post Study and a Focus Group Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04216056
• Other study ID #: 2019.455
• Status: Completed
• Phase: N/A
• Start date: January 3, 2020
• Est. completion date: May 25, 2022

Study information

• Verified date: May 2022
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 185
• Est. completion date: May 25, 2022
• Est. primary completion date: March 29, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Frailty

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
China	Chinese University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Weight	Weight in kilogram measured using standardized method.	baseline, 12 weeks
Other	Height	Height in centimeter measured using standardized method.	baseline, 12 weeks
Other	Waist circumference	Waist circumference in centimeter measured using standardized method.	baseline, 12 weeks
Other	Systolic blood pressure	Systolic blood pressure in mmHg measured using standardized method.	baseline, 12 weeks
Other	Diastolic blood pressure	Diastolic blood pressure in mmHg measured using standardized method.	baseline, 12 weeks
Other	Fat mass percentage	This outcome will be measured using bioelectrical impedance analysis (BIA).	baseline, 12 weeks
Other	Fat free mass percentage	This outcome will be measured using bioelectrical impedance analysis (BIA).	baseline, 12 weeks
Primary	Change in gait speed	This outcome will be measured using the 6-meter walk test.	baseline, 12 weeks
Secondary	Frailty status	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
Secondary	Handgrip strength	Handgrip strength will be measured using a dynamometer.	baseline, 12 weeks
Secondary	5 chair stands	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
Secondary	Balance test	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
Secondary	Cognitive performance	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
Secondary	Dietary intake	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
Secondary	Nutritional status	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
Secondary	Physical activity	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
Secondary	Self-rated health	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
Secondary	Life satisfaction	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
Secondary	Self-efficacy of chronic disease management	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
Secondary	Views towards the frailty intervention program	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