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Evaluation of a Frailty Intervention Program in Hong Kong

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ClinicalTrials.gov Identifier: NCT04216056
Recruitment Status : Recruiting
First Posted : January 2, 2020
Last Update Posted : January 7, 2020
Sponsor:
Information provided by (Responsible Party):
Ruth Chan, Chinese University of Hong Kong

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.


Condition or disease Intervention/treatment Phase
Frailty Behavioral: Frailty intervention program Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 152 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of a Frailty Intervention Program in Hong Kong: A Pre-Post Study and a Focus Group Study
Actual Study Start Date : January 3, 2020
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : August 2022

Arm Intervention/treatment
Experimental: 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.
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.

No Intervention: Control group
Subjects in the control group will be asked to maintain their usual diet and physical activity patterns over the 12 weeks.



Primary Outcome Measures :
  1. Change in gait speed [ Time Frame: baseline, 12 weeks ]
    This outcome will be measured using the 6-meter walk test.


Secondary Outcome Measures :
  1. Frailty status [ Time Frame: baseline, 12 weeks ]
    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.

  2. Handgrip strength [ Time Frame: baseline, 12 weeks ]
    Handgrip strength will be measured using a dynamometer.

  3. 5 chair stands [ Time Frame: baseline, 12 weeks ]
    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.

  4. Balance test [ Time Frame: baseline, 12 weeks ]
    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.

  5. Cognitive performance [ Time Frame: baseline, 12 weeks ]
    Frontal Assessment Battery will be used to assess executive function. Total score is a maximum of 18, higher scores indicating better performance.

  6. Dietary intake [ Time Frame: baseline, 12 weeks ]
    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.

  7. Nutritional status [ Time Frame: baseline, 12 weeks ]
    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.

  8. Physical activity [ Time Frame: baseline, 12 weeks ]
    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.

  9. Self-rated health [ Time Frame: baseline, 12 weeks ]
    This outcome will be elicited by a single question, "Generally speaking, how is your health: excellent, very good, good, fair, or poor?" .

  10. Life satisfaction [ Time Frame: baseline, 12 weeks ]
    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.

  11. Self-efficacy of chronic disease management [ Time Frame: baseline, 12 weeks ]
    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.

  12. Views towards the frailty intervention program [ Time Frame: 12 weeks ]
    Participants in the intervention group will be invited to share their experience and opinion in focus groups (of 1 to 1.5 hours duration).


Other Outcome Measures:
  1. Weight [ Time Frame: baseline, 12 weeks ]
    Weight in kilogram measured using standardized method.

  2. Height [ Time Frame: baseline, 12 weeks ]
    Height in centimeter measured using standardized method.

  3. Waist circumference [ Time Frame: baseline, 12 weeks ]
    Waist circumference in centimeter measured using standardized method.

  4. Systolic blood pressure [ Time Frame: baseline, 12 weeks ]
    Systolic blood pressure in mmHg measured using standardized method.

  5. Diastolic blood pressure [ Time Frame: baseline, 12 weeks ]
    Diastolic blood pressure in mmHg measured using standardized method.

  6. Fat mass percentage [ Time Frame: baseline, 12 weeks ]
    This outcome will be measured using bioelectrical impedance analysis (BIA).

  7. Fat free mass percentage [ Time Frame: baseline, 12 weeks ]
    This outcome will be measured using bioelectrical impedance analysis (BIA).



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04216056


Contacts
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Contact: Ruth Chan, PhD +852 35052190 ruthchansm@cuhk.edu.hk

Locations
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China
Chinese University of Hong Kong Recruiting
Hong Kong, China
Contact: Ruth Chan, PhD    852 3505 2190    ruthchansm@cuhk.edu.hk   
Principal Investigator: Ruth Chan, PhD         
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
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Principal Investigator: Ruth Chan, PhD Chinese University of Hong Kong
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Responsible Party: Ruth Chan, Senior Research Fellow, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT04216056    
Other Study ID Numbers: 2019.455
First Posted: January 2, 2020    Key Record Dates
Last Update Posted: January 7, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Frailty
Pathologic Processes