Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000598583
Ethics application status
Approved
Date submitted
8/12/2023
Date registered
9/05/2024
Date last updated
9/05/2024
Date data sharing statement initially provided
9/05/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Modified elastic band with a coconut shell on muscle strength and balance in the elderly
Scientific title
Effects of exercise using a modified elastic band with a coconut shell on muscle strength and balance in community-dwelling older adults: A randomized controlled trial study
Secondary ID [1] 311097 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sarcopenia 332251 0
Condition category
Condition code
Musculoskeletal 328970 328970 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The participants were randomly assigned to either the exercise (n=15) or control groups (n=15). All training sessions were performed under the supervision of a physiotherapist. The exercise group used a modified elastic band with a coconut shell three days a week for four weeks. Both groups received a single educational session on fall prevention after a baseline assessment. The Functional Reach Test (FRT) and Timed Up and Go Test (TUG) were used to assess balance, respectively. The 30-second chair stand test (30CST) was also used to measure leg strength. All outcome parameters were measured at the beginning of the study, immediately after a single exercise session, and after four weeks of exercise. The intensity of program consisted of two level including low (7-11) and moderate (12-14) dose due to progression assessed by RPE.

In this study, a home-based exercise program was established. The elastic band resistance training program consisted of the warm-up phase, exercise condition, and cool-down phase. Each program session lasted for around 45 minutes. During the warm-up phase, stretching (four positions), general active exercise (three positions), and self-foot massage (two positions) were performed, respectively. In the exercise condition, 11 positions involving upper and lower limb resistance were performed using a modified elastic band with a coconut shell. Theses exercises included biceps curls, shoulder abduction, and seat knee flexion and extension. The participants performed 2–3 sets of 10–15 repetitions for each exercise. For the cool-down phase, self-foot massage (one position) and breathing exercise (two positions) were performed, respectively.

For the first two weeks of the program, all participants in the exercise group were asked to perform two sets of 10 repetitions per exercise position. After two weeks of the program, all participants in the exercise group were asked to perform three sets of 15 repetitions per exercise position for progressive overload training.

The exercise equipment was made from one piece of coconut shell (diameter x height: 6 x 3 inches) and connected with an elastic band. For the first two weeks of the program, the elastic band was made from 240 rubber bands (diameter 1 inch). After two weeks of exercise, an elastic band made from 360 rubber bands was then used for the purposes of training progression.

All participants in the exercise group received an exercise poster, logbook, and weekly phone call to assist and facilitate their exercises. Meanwhile, the control group was asked to maintain their activities of daily life and received a telephone call once a week.
Intervention code [1] 327547 0
Treatment: Other
Comparator / control treatment
The experimental group performed the exercise using elastic and a coconut shell three days a week for four consecutive weeks, while the control group did not perform the exercise. Both groups received a single educational session on fall prevention after a baseline assessment.

The education session was about fall prevention providing detail of causes of fall and how to perform daily activities to minimize risk factors of fall. The duration approximately took 30 minutes. The session was administered by the researcher team which were experienced physiotherapists. The participants were monitored by logbook and phone call once a week.
Control group
Active

Outcomes
Primary outcome [1] 336821 0
The 30-second chair stand test (30CST)
Timepoint [1] 336821 0
It was measured at the beginning of the study, immediately after a single exercise session, and after four weeks of exercise (primary endpoint).
Primary outcome [2] 336822 0
Time up and go test (TUG)
Timepoint [2] 336822 0
It was measured at the beginning of the study, immediately after a single exercise session, and after four weeks of exercise (primary endpoint).
Secondary outcome [1] 429739 0
Functional reach test (FRT)
Timepoint [1] 429739 0
It was measured at the beginning of the study, immediately after a single exercise session, and after four weeks of exercise.

Eligibility
Key inclusion criteria
1) aged 60 years and older, 2) able to stand and walk independently, 3) able to follow instructions, 4) received a Thai Mental State Examination (TMSE) score of more than 23 points, and 5) expressed a willingness to participate in the research.
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1) a history of ischemic heart disease, heart failure, dizziness due to low blood pressure (hypotension), uncontrolled high blood pressure, deep vein thrombosis or acute arthritis/arthralgia, and 2) open wounds in and around the feet.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software.
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
5/08/2023
Date of last participant enrolment
Anticipated
Actual
17/09/2023
Date of last data collection
Anticipated
Actual
1/10/2023
Sample size
Target
30
Accrual to date
Final
29
Recruitment outside Australia
Country [1] 26024 0
Thailand
State/province [1] 26024 0
Phayao

Funding & Sponsors
Funding source category [1] 315356 0
University
Name [1] 315356 0
University of Phayao
Country [1] 315356 0
Thailand
Primary sponsor type
Individual
Name
Panida Hanphitakphong
Address
School of Allied Health Sciences, University of Phayao 19 Moo 2 Tambon Maeka Amphur Muang Phayao 56000
Country
Thailand
Secondary sponsor category [1] 317416 0
None
Name [1] 317416 0
Address [1] 317416 0
Country [1] 317416 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314275 0
University of Phayao Human Ethics Committee
Ethics committee address [1] 314275 0
Ethics committee country [1] 314275 0
Thailand
Date submitted for ethics approval [1] 314275 0
22/04/2023
Approval date [1] 314275 0
28/05/2023
Ethics approval number [1] 314275 0
UP-HEC 1.2/096/66

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

Contacts
Principal investigator
Name 131022 0
Dr Panida Hanphitakphong
Address 131022 0
School of Allied Health Sciences, University of Phayao 19 Moo 2 Tambon Maeka Amphur Muang Phayao 56000
Country 131022 0
Thailand
Phone 131022 0
+6654466697
Fax 131022 0
Email 131022 0
[email protected]
Contact person for public queries
Name 131023 0
Panida Hanphitakphong
Address 131023 0
School of Allied Health Sciences, University of Phayao 19 Moo 2 Tambon Maeka Amphur Muang Phayao 56000
Country 131023 0
Thailand
Phone 131023 0
+6654466697
Fax 131023 0
Email 131023 0
[email protected]
Contact person for scientific queries
Name 131024 0
Panida Hanphitakphong
Address 131024 0
School of Allied Health Sciences, University of Phayao 19 Moo 2 Tambon Maeka Amphur Muang Phayao 56000
Country 131024 0
Thailand
Phone 131024 0
+6654466697
Fax 131024 0
Email 131024 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.