Evaluation of a Frailty Intervention Program in Hong Kong

NCT04216056 | Completed

• 1 other identifier: 2019.455
• Study Type: interventional
• Target: 185
• Locations: 1 country
• Sites: 1

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.

Conditions

Frailty

Outcome Measures

Primary Outcomes (1)

• Change in gait speed

  This outcome will be measured using the 6-meter walk test.

  baseline, 12 weeks

Secondary Outcomes (12)

• Frailty status

  baseline, 12 weeks

• Handgrip strength

  baseline, 12 weeks

• 5 chair stands

  baseline, 12 weeks

• Balance test

  baseline, 12 weeks

• Cognitive performance

  baseline, 12 weeks

Other Outcomes (7)

• Weight

  baseline, 12 weeks

• Height

  baseline, 12 weeks

• Waist circumference

  baseline, 12 weeks

Study Arms (2)

Frailty intervention program

EXPERIMENTAL

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.

Behavioral: Frailty intervention program

Control group

NO INTERVENTION

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

Interventions

Frailty intervention program 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.

Frailty intervention program

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Chinese University of Hong Kong

Hong Kong, China

Location

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jean Woo, MD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 23, 2019
• First Posted: January 2, 2020
• Study Start: January 3, 2020
• Primary Completion: March 29, 2022
• Study Completion: May 25, 2022
• Last Updated: May 26, 2022

Record last verified: 2022-05

Locations

CN (1)