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CompletedNCT05025137Updated Aug 27, 2021

Flexi-Bar and Multi-Component Exercises

An interventional study of Flexi-Bar Exercise and Multi-Component exercise in Older Adults, sponsored by Yang Shang-Yu. Completed at 1 site in Taiwan. Open to participants aged 65 Years to 88 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-08-27.

Sponsored by Yang Shang-Yu · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Registered 11 months after the study started (first participant enrolled Sep 2020, registered Aug 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
65 Years to 88 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Older Adults
03

In context

Lead sponsor

Yang Shang-Yu is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years to 88 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • (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).

Exclusion criteria

Exclusion Criteria:

  • (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.
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Flexi-Bar group

    Participants in the Flexi-Bar group performed a 60-minute Flexi-Bar exercise every week for 12 consecutive weeks.

    Other: Flexi-Bar Exercise

  • Experimental
    Multi-Component exercise group

    Participants in the Multi-Component exercise group performed a 60-minute Multi-Component exercise every week for 12 consecutive weeks.

    Other: Multi-Component exercise

Interventions

  • OtherFlexi-Bar Exercise

    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).

  • OtherMulti-Component exercise

    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.

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: 10-15 minutes

Secondary outcomes

  1. 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.

    Time frame: 30-40 minutes

  2. 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.

    Time frame: 10-15 minutes

07

Study locations

1 site
  • Asia University
    Taichung, WuFeng 41354, Taiwan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 27, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05025137
Lead sponsor
Yang Shang-Yu
Responsible party
Yang Shang-Yu (Assistant professor, National Cheng Kung University) — Sponsor-investigator
First posted
Aug 27, 2021
Start date
Sep 1, 2020
Primary completion
Jan 30, 2021
Completion
May 30, 2021
Last update
Aug 27, 2021

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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