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Clinical Trials/NCT04216056
NCT04216056
Completed
N/A

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

Chinese University of Hong Kong1 site in 1 country185 target enrollmentJanuary 3, 2020
ConditionsFrailty

Overview

Phase
N/A
Intervention
Not specified
Conditions
Frailty
Sponsor
Chinese University of Hong Kong
Enrollment
185
Locations
1
Primary Endpoint
Change in gait speed
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 3, 2020
End Date
May 25, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jean Woo

Professor

Chinese University of Hong Kong

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.

Outcomes

Primary Outcomes

Change in gait speed

Time Frame: baseline, 12 weeks

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

Secondary Outcomes

  • Frailty status(baseline, 12 weeks)
  • Nutritional status(baseline, 12 weeks)
  • Life satisfaction(baseline, 12 weeks)
  • Handgrip strength(baseline, 12 weeks)
  • 5 chair stands(baseline, 12 weeks)
  • Balance test(baseline, 12 weeks)
  • Cognitive performance(baseline, 12 weeks)
  • Dietary intake(baseline, 12 weeks)
  • Physical activity(baseline, 12 weeks)
  • Self-rated health(baseline, 12 weeks)
  • Self-efficacy of chronic disease management(baseline, 12 weeks)
  • Views towards the frailty intervention program(12 weeks)

Study Sites (1)

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