Flexi-Bar and Multi-Component Exercises

NCT05025137 | Completed

• 1 other identifier: CRREC-109
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Older Adults

Outcome Measures

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).

  10-15 minutes

Secondary Outcomes (2)

• Senior Fitness Test

  30-40 minutes

• Nordic Musculoskeletal Questionnaire

  10-15 minutes

Study Arms (2)

Flexi-Bar group

EXPERIMENTAL

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

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.

Other: Multi-Component exercise

Interventions

Flexi-Bar Exercise OTHER

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).

Flexi-Bar group

Multi-Component exercise OTHER

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.

Multi-Component exercise group

Eligibility Criteria

• Age: 65 Years - 88 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• (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).

You may not qualify if:

• (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.

Sponsors & Collaborators

• Yang Shang-Yu: lead

Study Sites (1)

Asia University

Taichung, WuFeng, 41354, Taiwan

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: August 23, 2021
• First Posted: August 27, 2021
• Study Start: September 1, 2020
• Primary Completion: January 30, 2021
• Study Completion: May 30, 2021
• Last Updated: August 27, 2021

Record last verified: 2021-08

Locations

TW (1)