Evaluation of a Frailty Intervention Program in Hong Kong

NCT ID: NCT04216056

Last Updated: 2022-05-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 185 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-03
• Study Completion Date: 2022-05-25

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.

Conditions

Frailty

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Frailty intervention program

Intervention Type: BEHAVIORAL

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.

Control group

Subjects in the control group will be asked to maintain their usual diet and physical activity patterns over the 12 weeks.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Jean Woo

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jean Woo, MD

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

Chinese University of Hong Kong

Hong Kong, , China

Countries

China

Other Identifiers

2019.455

Identifier Type: -

Identifier Source: org_study_id