NCT04887363

Brief Summary

Core muscles and core stability has a key component in the postural control or balance. However, no clear evidence has been found for the positive relationship between core stability and postural control in the elderly, and the effects of core stabilizing training on postural control or balance in the elderly. The purposes of this project are to investigate the effects of core stability training program on muscle strength, muscle performance, and balance outcomes in elderly adults.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2013

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 3, 2013

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2015

Completed
5.7 years until next milestone

First Submitted

Initial submission to the registry

March 22, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 14, 2021

Completed
Last Updated

May 14, 2021

Status Verified

February 1, 2021

Enrollment Period

2.1 years

First QC Date

March 22, 2021

Last Update Submit

May 11, 2021

Conditions

Outcome Measures

Primary Outcomes (8)

  • Changes in strength of core muscle groups (trunk) at 12-week

    Using a custom-made isometric dynamometer to measure the strength of trunk flexors, extensors and rotators

    The assessments will be conducted 1 and 12 weeks following the intervention

  • Changes in strength of core muscle groups (hip) at 12-week

    Using a hand-held dynamometer to measure the hip muscle strength

    The assessments will be conducted 1 and 12 weeks following the intervention

  • Changes in endurance of core muscle groups at 12-week

    Using the Stabilizer Pressure Biofeedback Unit (PBU) during the leg-loading test to measure the endurance of lumbo-pelvic stability

    The assessments will be conducted 1 and 12 weeks following the intervention

  • Changes in flexibility of the lower back and hamstring muscles at 12-week

    Using the sit and reach test to measure the flexibility of the lower back and hamstring muscles

    The assessments will be conducted 1 and 12 weeks following the intervention

  • Changes in ability of the dynamic balance at 12-week

    Using the Dual-tasking 3m Timed up and go (3m-TUG) to measure dynamic balance and the fall risk. Mean time to perform 3m-TUG is 11.56 seconds

    The assessments will be conducted 1 and 12 weeks following the intervention

  • Changes in assessment of postural control at 12-week

    Using a force plate to collect the center of pressure (COP) displacement

    The assessments will be conducted 1 and 12 weeks following the intervention

  • Changes in muscle activity of selected core muscles during performing arm-raising tasks at 12-week

    Using a surface electromyography to record the muscle activity of abdominal and trunk muscles during performing arms-raising tasks with hand-holding 1.5-2 kg

    The assessments will be conducted 1 and 12 weeks following the intervention

  • Changes in assessment of postural control during performing arm-raising tasks at 12-week

    Using a force plate to collect the center of pressure (COP) displacement during performing arms-raising tasks with hand-holding 1.5-2 kg

    The assessments will be conducted 1 and 12 weeks following the intervention

Study Arms (3)

Core exercise group

EXPERIMENTAL

The healthy community-dwelling older adults (60-74 years old), who had not received any core stability or Tai Chi Chuan training within the previous 6 months, were recruited in this study. All the subjects were independent in basic daily living activities and able to move freely without any assistance.

Behavioral: Core exercise

Tai Chi exercise group

EXPERIMENTAL

The healthy community-dwelling older adults (60-74 years old), who had not received any core stability or Tai Chi Chuan training within the previous 6 months, were recruited in this study. All the subjects were independent in basic daily living activities and able to move freely without any assistance.

Behavioral: Tai Chi exercise

Young adults group

NO INTERVENTION

The healthy young adults who have not any neurological, musculoskeletal or rheumatic disease were recruited as a reference group. They would not receive any training program in the study.

Interventions

Core exerciseBEHAVIORAL

Participants will receive12-week, 60 minutes, 36-session exercise-based core stability training class. Participants need complete baseline assessments of muscle performance, and balance ability measures 1 week prior and 1 week and 12 weeks following the intervention. All subjects will receive two post-exercise measurements at 13th week and 25th week.

Core exercise group

Participants will receive 12-week, 60 minutes, 36-session Tai Chi exercise training class. Participants need complete baseline assessments of muscle performance, and balance ability measures 1 week prior and 1 week and 12 weeks following the intervention. All subjects will receive two post-exercise measurements at 13th week and 25th week.

Tai Chi exercise group

Eligibility Criteria

Age20 Years - 74 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Core exercise group and Tai Chi exercise group
  • healthy community-dwelling older adults (60-74 years old)
  • not received any core stability or Tai Chi Chuan training within the previous 6 months
  • independent in basic daily living activities
  • able to move freely without any assistance
  • Young adults group a. Their age should be ranged between 20 - 59 years

You may not qualify if:

  • All group
  • have a history of orthopedic surgery on spine or lower extremity
  • have any spine pathology (e.g., spondylolisthesis, disc herniation)
  • have a pain over back or lower limbs to affect the ability to perform activities of daily living
  • had a history of vestibular disease (e.g., Meniere' s disease)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Aquatic Therapy

Intervention Hierarchy (Ancestors)

HydrotherapyPhysical Therapy ModalitiesTherapeuticsRehabilitation

Study Officials

  • Li-Jiun Liaw

    Kaohsiung Medical University Department of Physical Therapy Associate Professor

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2021

First Posted

May 14, 2021

Study Start

June 3, 2013

Primary Completion

June 30, 2015

Study Completion

June 30, 2015

Last Updated

May 14, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Currently in the submission stage ,and then share with other researchers after publication