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Trial registered on ANZCTR


Registration number
ACTRN12617001036303
Ethics application status
Approved
Date submitted
17/05/2017
Date registered
17/07/2017
Date last updated
2/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of an exercise and game training program for frailty in Hong Kong: a randomized controlled trial and a focus group study
Scientific title
Evaluation of an exercise and game training program on frailty status in pre-frail and frail elderly in Hong Kong: a randomized controlled trial and a focus group study
Secondary ID [1] 291252 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Frailty 302181 0
Condition category
Condition code
Musculoskeletal 301790 301790 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Subjects assigned to the intervention group will be invited to participate in a frailty intervention 2 sessions/week over a 12 week period. The duration of each session will be 2 hours. Each session consists of exercise training (1 hour/session) provided by a personal trainer and game training (1 hour/session) provided by a trained research assistant, which will be conducted in groups (6-10 subjects/group). Each exercise session will begin and end with a 5-10 minute warm-up and cool-down routine that consists of stretching of the main muscle groups being trained. The first part of the exercise program consists of 20-30 minute aerobic exercises, which include movements of the main muscle groups. These exercises include swinging legs, walking on the spot, stepping, circling shoulders, touching toes, clapping hands, stamping feet etc. The intensity of the aerobic training stimulus will be set at approximately 40% of one’s age specific target heart rate (i.e., heart rate reserve; HRR) and be progressed to the range of 70-80% of HRR. Exercise intensity will be monitored through heart rate monitors. Subjects will be asked to aim for 13-15 on the Rating of Perceived Exertion (RPE) during the aerobic sessions. The aerobic component will last for 20-30 minutes. A 5-minute rest period will be given prior to the start of the second part of the exercise program that consists of 20-30 minute resistance exercises using Thera-Bands, dumbbells, or other resistance training equipment. for muscle groups in both the upper (chest, back, biceps, triceps) and lower body (knee extension/flexion, heel raises, side leg lifts). Initial strength assessment will be conducted by trained research personnel on the first day of exercise intervention to estimate each individual’s one-repetition maximum (1RM, the maximal load that could be lifted fully one time only) using a submaximal 8-12RM test for each set of exercise. For the actual training, subjects will be instructed to perform each movement against 60-80% of the estimated 1RM load. Higher resistance will be added progressively based on their subjective ratings of muscle effort during the exercise. Number of repetitions (up to 12) and sets (1 to 4 sets) will also increase progressively throughout the entire intervention period. Overall, the exercises are easy to learn and are designed to include variations and gradual progression to higher intensity. For the game training, a selection of video games, board games, and card games will be used according to subject's choice. Subjects will also be invited to share their attitudes and expectations toward doing exercise and game training in focus groups. Six focus groups will be held. Each focus group will have around 6 subjects, resulting in a total of 36 subjects
Intervention code [1] 297256 0
Lifestyle
Comparator / control treatment
Subjects assigned to the control group will receive no treatment between pre- and post-assessments and will receive the same frailty intervention after the 12 week intervention period.
Control group
Active

Outcomes
Primary outcome [1] 301196 0
Change in frailty status after the intervention when compared with the baseline level. Frailty will be measured using the FRAIL scale
Timepoint [1] 301196 0
Baseline and post-intervention (12 weeks)
Primary outcome [2] 301197 0
Change in gait speed after the intervention when compared with the baseline level.. Gait speed will be measured during a simple walking course that involved walking 6 meters at a usual pace
Timepoint [2] 301197 0
Baseline and post-intervention (12 weeks)
Secondary outcome [1] 331999 0
Change in hand-grip strength after the intervention when compared with the baseline level. Hand-grip strength will be measured using a dynamometer
Timepoint [1] 331999 0
Baseline and post-intervention (12 weeks)
Secondary outcome [2] 332000 0
Change in muscle endurance in the lower extremities after the intervention when compared with the baseline level. Muscle endurance in the lower extremities will be measured using 5 chair stand test
Timepoint [2] 332000 0
Baseline and post-intervention (12 weeks)
Secondary outcome [3] 332001 0
Change in balance after the intervention when compared with the baseline level. Balance test will be performed to evaluate the ability to maintain balance of participant. Subjects 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
Timepoint [3] 332001 0
Baseline and post-intervention (12 weeks)
Secondary outcome [4] 332002 0
Change in cognitive function after the intervention when compared with the baseline level. Dual-tasking gait assessment will be performed to estimate cognitive function
Timepoint [4] 332002 0
Baseline and post-intervention (12 weeks)
Secondary outcome [5] 332003 0
Change in executive function after the intervention when compared with the baseline level. Frontal Assessment Battery (FAB) will be used to assess executive function
Timepoint [5] 332003 0
Baseline and post-intervention (12 weeks)
Secondary outcome [6] 332004 0
Change in working memory after the intervention when compared with the baseline level. Wechsler digit span task will be used to assess working memory
Timepoint [6] 332004 0
Baseline and post-intervention (12 weeks)
Secondary outcome [7] 332005 0
Change in self-rated health after the intervention when compared with the baseline level. Self-rated health will be elicited by a single question, “Generally speaking, how is your health: excellent, very good, good, fair, or poor?”
Timepoint [7] 332005 0
Baseline and post-intervention (12 weeks)
Secondary outcome [8] 332006 0
Change in life satisfaction after the intervention when compared with the baseline level. Life satisfaction will be assessed by the subjects' response to the question "Are you satisfied with life?", using a 0-10 point linear scale
Timepoint [8] 332006 0
Baseline and post-intervention (12 weeks)
Secondary outcome [9] 336337 0
Attitudes towards doing exercise will be assessed from the focus group study
Timepoint [9] 336337 0
Post-intervention (12 weeks)
Secondary outcome [10] 336338 0
Expectations towards doing exercise will be assessed from the focus group study
Timepoint [10] 336338 0
Post-intervention (12 weeks)
Secondary outcome [11] 336339 0
Attitudes towards game training will be assessed from the focus group study
Timepoint [11] 336339 0
Post-intervention (12 weeks)
Secondary outcome [12] 336340 0
Expectations towards game training will be assessed from the focus group study
Timepoint [12] 336340 0
Post-intervention (12 weeks)

Eligibility
Key inclusion criteria
People aged 50 years or older will be identified in community facilities (e.g., neighbourhood elderly centre, social centre for the elderly). They will be invited for a brief screening using the FRAIL scale. Those meeting the criteria for potentially pre-frail / frail according to the FRAIL score (score >= 1) will be invited for further assessment. To be eligible for the study, the subjects should further fulfill the following inclusion and exclusion 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.
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
This is a single blind randomized controlled trial. After eligibility check, subjects who agree to join the study will be randomly allocated into either the control or intervention group. Simple randomization will be adopted using computer-generated random numbers, sealed in an opaque envelope. Treatment assignment will be done by an independent person by opening the envelops with consecutive numbers for eligible subjects. Subjects will aware of the treatment assigned. The outcome assessors will remain blinded to treatment allocation until the data entry is complete.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/08/2017
Actual
1/08/2017
Date of last participant enrolment
Anticipated
30/04/2019
Actual
Date of last data collection
Anticipated
31/07/2019
Actual
Sample size
Target
120
Accrual to date
100
Final
Recruitment outside Australia
Country [1] 8686 0
Hong Kong
State/province [1] 8686 0

Funding & Sponsors
Funding source category [1] 295707 0
Charities/Societies/Foundations
Name [1] 295707 0
The Hong Kong Jockey Club Charities Trust
Country [1] 295707 0
Hong Kong
Primary sponsor type
Individual
Name
Jean Woo
Address
Department of Medicine & Therapeutics, 9/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, 30-32 Ngan Shing Steet, Shatin, New Territories, Hong Kong (Postal code is not used in Hong Kong)
Country
Hong Kong
Secondary sponsor category [1] 294545 0
Individual
Name [1] 294545 0
Ruby Yu
Address [1] 294545 0
Suite 602, 6/F, Yasumoto International Academic Park, The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong (The street number and name in the address is not available. Postal code is not used in Hong Kong)
Country [1] 294545 0
Hong Kong

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297010 0
Join Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee
Ethics committee address [1] 297010 0
Ethics committee country [1] 297010 0
Hong Kong
Date submitted for ethics approval [1] 297010 0
Approval date [1] 297010 0
10/01/2017
Ethics approval number [1] 297010 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 72710 0
Prof Jean Woo
Address 72710 0
Department of Medicine & Therapeutics, 9/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, 30-32 Ngan Shing Steet, Shatin, New Territories, Hong Kong (Postal code is not used in Hong Kong)
Country 72710 0
Hong Kong
Phone 72710 0
+852 35053141
Fax 72710 0
Email 72710 0
[email protected]
Contact person for public queries
Name 72711 0
Ruby Yu
Address 72711 0
Suite 602, 6/F, Yasumoto International Academic Park, The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong (The street number and name in the address is not available. Postal code is not used in Hong Kong)
Country 72711 0
Hong Kong
Phone 72711 0
+852 39435142
Fax 72711 0
Email 72711 0
[email protected]
Contact person for scientific queries
Name 72712 0
Ruby Yu
Address 72712 0
Suite 602, 6/F, Yasumoto International Academic Park, The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong (The street number and name in the address is not available. Postal code is not used in Hong Kong)
Country 72712 0
Hong Kong
Phone 72712 0
+852 39435142
Fax 72712 0
Email 72712 0
[email protected]

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No Supporting Document Provided



Results publications and other study-related documents

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