Older AdultsNCT05025137
Flexi-Bar and Multi-Component Exercises
A study testing Flexi-Bar Exercise and Multi-Component exercise in people with Older Adults, run by Yang Shang-Yu at 1 site in Taiwan.
Trial summary
Background: Previous studies have suggested that both Flexi-Bar and Multi-Component exercises can improve an individual's physical fitness and musculoskeletal discomfort. However, determining which is more effective in enhancing the frailty, physical fitness, and musculoskeletal discomfort of the elderly remains… Read more about this study
- Who is it for?
- Ages 65 to 88 yearsHealthy volunteers can take part
- Conditions the study is for
- Older Adults
- What is being tested?
- Flexi-Bar Exercise and Multi-Component exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Sep 2020to 30 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 88 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- (1) participants aged 65 years and over;
- (2) participants who could communicate in Mandarin or Taiwanese and cooperate with sports activities; and
- (3) participants who could walk independently without assistance (or with aid).
Who cannot join
- (1) participants with unstable physiological conditions (or those who were recommended against participating in physical activities by their doctor);
- (2) participants with unstable mental conditions; and
- (3) participants who could not complete the 12-week exercise intervention.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing the Effectiveness of Flexi-Bar and Multi-Component Exercises on Improving the Frailty, Physical Fitness, and Musculoskeletal Discomfort of Older Adults: a Randomized Controlled Trial
Background: Previous studies have suggested that both Flexi-Bar and Multi-Component exercises can improve an individual's physical fitness and musculoskeletal discomfort. However, determining which is more effective in enhancing the frailty, physical fitness, and musculoskeletal discomfort of the elderly remains controversial.
Objective: This study aims to investigate differences in the effectiveness of Flexi-Bar and Multi-Component exercises in improving the frailty, physical fitness, and musculoskeletal discomfort of the elderly after 12 weeks of intervention.
Methods: A single-blind randomized controlled trial was conducted to collect data from a city in central Taiwan. Participants were randomly divided into a Flexi-Bar group (FB group) and a Multi-Component exercise group (MCE group). Participants in the FB group performed a 60-minute Flexi-Bar exercise every week for 12 consecutive weeks. Meanwhile, Participants in the MCE group performed a 60-minute Multi-Component exercise every week for 12 consecutive weeks. Tests were conducted both before and after the 12-week intervention using items including the Kihon Checklist, Senior Fitness Test, and Nordic Musculoskeletal Questionnaire.
- Conditions
- Older Adults
- Being tested
- Flexi-Bar Exercise, Multi-Component exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flexi-Bar ExerciseOther
In the experimental group, the Flexi-Bar was adopted as the tool for active vibration exercises. Featuring light weight and ease of operation, it weighs only 460 grams and has a vibration frequency of 4-5 Hz. With diversified functions, the Flexi-Bar can improve posture, burn fat, strengthen connective tissue, enhance body shape, and increase muscle strength.
The 12-week Flexi-Bar exercise course in this study was created by two assistant professors specializing in rehabilitation (one with an occupational therapy certificate and the other with a physical therapy certificate). The course, composed of one 60-minute class per week for a total of 12 weeks, progressed gradually from basic activities (e.g., standing with both feet) to advanced activities (e.g., standing with one foot).
Multi-Component exerciseOther
Alternatively, in the control group, the Multi-Component exercise was adopted, which included aerobic, resistance, flexibility, and balance exercises. The course was composed of one 60-minute class per week for a total of 12 weeks. The design was based on the ACSM's recommendations for the multiple-component exercise of the elderly (Chodzko-Zajko et al., 2009) and videos of the National Health Exercises for the Elderly formulated by the Ministry of Health and Welfare (Ministry of Health and Welfare, 2017). The course was created and led by a physical therapist to gradually progress from sitting postures to standing and walking postures. Additionally, the intensity of the exercises was adjusted according to the participants' physical conditions; fitness equipment was introduced when appropriate.
| Study group | Role | What they receive |
|---|---|---|
| Flexi-Bar group | Experimental | Participants in the Flexi-Bar group performed a 60-minute Flexi-Bar exercise every week for 12 consecutive weeks. Receives: Other: Flexi-Bar Exercise |
| Multi-Component exercise group | Experimental | Participants in the Multi-Component exercise group performed a 60-minute Multi-Component exercise every week for 12 consecutive weeks. Receives: Other: Multi-Component exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kihon Checklist
The KCL consists of 25 True or False questions and covers seven aspects, including living independence, exercise function, nutrition, oral function, social interaction, dementia, and depression. The total score of all items, which ranged between 0 and 25, was then used to evaluate the participant's frailty. Participants with a score of 10 and greater were categorized as the frail population. The higher the score, the higher the degree of frailty. The reliability and validity of the Chinese version of the KCL was well verified (Tsay et al., 2018).
Measured: 10-15 minutes
Secondary outcomes (2)
Senior Fitness Test
The SFT was designed by Rikli and Jones (2013) to assess the physical fitness of the elderly in daily activities. It includes six tests, namely (1) chair stand test; (2) arm curl test; (3) 2-minute step test; (4) chair sit-and-reach test; (5) back scratch test; and (6) eight-foot up-and-go test.
Measured: 30-40 minutes
Nordic Musculoskeletal Questionnaire
Developed by Kuorinka et al. (1987), the NMQ asks participants whether they have experienced pain, soreness, numbness, tingling, or any other discomfort in 15 body parts on both sides (including neck, shoulders, upper back, elbows, lower back or waist, hands or wrists, hips or thighs, and knees and ankles or feet). The human body illustration in the questionnaire allows subjects to easily and clearly identify the location of musculoskeletal discomfort. The number of body parts with discomfort is then calculated by adding the number of locations experiencing any discomfort.
Measured: 10-15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2021
- Study start1 Sep 2020
- Primary completion30 Jan 2021
- Study completion30 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Older AdultsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yang Shang-Yu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yang Shang-Yu, National Cheng Kung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05025137
- Sponsor's protocol ID
- CRREC-109
- Status last verified
- Aug 2021
- First submitted
- 23 Aug 2021
- Last updated
- 27 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Effectiveness of Flexi-Bar and Multi-Component Exercises on Improving the Frailty, Physical Fitness, and Musculoskeletal Discomfort of Older Adults: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05025137
- Acronym / sponsor ID
- CRREC-109
- Conditions
- Older Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Yang Shang-YuUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 30 Jan 2021 (actual)
- Study completion
- 30 May 2021 (actual)
- First posted
- 27 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Previous studies have suggested that both Flexi-Bar and Multi-Component exercises can improve an individual's physical fitness and musculoskeletal discomfort. However, determining which is more effective in enhancing the frailty, physical fitness, and musculoskeletal discomfort of the elderly remains controversial.
Objective: This study aims to investigate differences in the effectiveness of Flexi-Bar and Multi-Component exercises in improving the frailty, physical fitness, and musculoskeletal discomfort of the elderly after 12 weeks of intervention.
Methods: A single-blind randomized controlled trial was conducted to collect data from a city in central Taiwan. Participants were randomly divided into a Flexi-Bar group (FB group) and a Multi-Component exercise group (MCE group). Participants in the FB group performed a 60-minute Flexi-Bar exercise every week for 12 consecutive weeks. Meanwhile, Participants in the MCE group performed a 60-minute Multi-Component exercise every week for 12 consecutive weeks. Tests were conducted both before and after the 12-week intervention using items including the Kihon Checklist, Senior Fitness Test, and Nordic Musculoskeletal Questionnaire.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flexi-Bar group | Experimental | Other: Flexi-Bar ExerciseParticipants in the Flexi-Bar group performed a 60-minute Flexi-Bar exercise every week for 12 consecutive weeks. |
| Multi-Component exercise group | Experimental | Other: Multi-Component exerciseParticipants in the Multi-Component exercise group performed a 60-minute Multi-Component exercise every week for 12 consecutive weeks. |
Who may qualify
- Ages
- 65 to 88 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- (1) participants aged 65 years and over;
- (2) participants who could communicate in Mandarin or Taiwanese and cooperate with sports activities; and
- (3) participants who could walk independently without assistance (or with aid).
Key exclusion criteria (3 listed)
- (1) participants with unstable physiological conditions (or those who were recommended against participating in physical activities by their doctor);
- (2) participants with unstable mental conditions; and
- (3) participants who could not complete the 12-week exercise intervention.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flexi-Bar ExerciseIn the experimental group, the Flexi-Bar was adopted as the tool for active vibration exercises. Featuring light weight and ease of operation, it weighs only 460 grams and has a vibration frequency of 4-5 Hz. With diversified functions, the Flexi-Bar can improve posture, burn fat, strengthen connective tissue, enhance body shape, and increase muscle strength. The 12-week Flexi-Bar exercise course in this study was created by two assistant professors specializing in rehabilitation (one with an occupational therapy certificate and the other with a physical therapy certificate). The course, composed of one 60-minute class per week for a total of 12 weeks, progressed gradually from basic activities (e.g., standing with both feet) to advanced activities (e.g., standing with one foot). | Other | Flexi-Bar group |
| Multi-Component exerciseAlternatively, in the control group, the Multi-Component exercise was adopted, which included aerobic, resistance, flexibility, and balance exercises. The course was composed of one 60-minute class per week for a total of 12 weeks. The design was based on the ACSM's recommendations for the multiple-component exercise of the elderly (Chodzko-Zajko et al., 2009) and videos of the National Health Exercises for the Elderly formulated by the Ministry of Health and Welfare (Ministry of Health and Welfare, 2017). The course was created and led by a physical therapist to gradually progress from sitting postures to standing and walking postures. Additionally, the intensity of the exercises was adjusted according to the participants' physical conditions; fitness equipment was introduced when appropriate. | Other | Multi-Component exercise group |
Primary outcome
Kihon Checklist
Time frame: 10-15 minutes
The KCL consists of 25 True or False questions and covers seven aspects, including living independence, exercise function, nutrition, oral function, social interaction, dementia, and depression. The total score of all items, which ranged between 0 and 25, was then used to evaluate the participant's frailty. Participants with a score of 10 and greater were categorized as the frail population. The higher the score, the higher the degree of frailty. The reliability and validity of the Chinese version of the KCL was well verified (Tsay et al., 2018).
2 secondary outcomes
Senior Fitness Test
Time frame: 30-40 minutes
Nordic Musculoskeletal Questionnaire
Time frame: 10-15 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flexi-Bar Exercise and Multi-Component exercise in people with Older Adults, run by Yang Shang-Yu at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kihon Checklist (time frame: 10-15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2021.