Clinical trial NCT04216056: Evaluation of a Frailty Intervention Program in Hong Kong
Official title: Evaluation of a Frailty Intervention Program in Hong Kong: A Pre-Post Study and a Focus Group Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frailty
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2020-01-02
Enrollment: 185
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in gait speed
timeFrame: baseline, 12 weeks
Secondary outcomes:
measure: Frailty status
timeFrame: baseline, 12 weeks
measure: Handgrip strength
timeFrame: baseline, 12 weeks
measure: 5 chair stands
timeFrame: baseline, 12 weeks
measure: Balance test
timeFrame: baseline, 12 weeks
measure: Cognitive performance
timeFrame: baseline, 12 weeks
measure: Dietary intake
timeFrame: baseline, 12 weeks
measure: Nutritional status
timeFrame: baseline, 12 weeks
measure: Physical activity
timeFrame: baseline, 12 weeks
measure: Self-rated health
timeFrame: baseline, 12 weeks
measure: Life satisfaction
timeFrame: baseline, 12 weeks
measure: Self-efficacy of chronic disease management
timeFrame: baseline, 12 weeks
measure: Views towards the frailty intervention program
timeFrame: 12 weeks
Other outcomes:
measure: Weight
timeFrame: baseline, 12 weeks
measure: Height
timeFrame: baseline, 12 weeks
measure: Waist circumference
timeFrame: baseline, 12 weeks
measure: Systolic blood pressure
timeFrame: baseline, 12 weeks
measure: Diastolic blood pressure
timeFrame: baseline, 12 weeks
measure: Fat mass percentage
timeFrame: baseline, 12 weeks
measure: Fat free mass percentage
timeFrame: baseline, 12 weeks
Locations:
city: Hong Kong
country: China
facility: Chinese University of Hong Kong
Study officials:
affiliation: Chinese University of Hong Kong
name: Jean Woo, MD
role: PRINCIPAL_INVESTIGATOR
References: