Effectiveness of Interactive Exergame in Older Adults With Sarcopenia

NCT04770558 | Unknown

• 1 other identifier: N202012029
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Sarcopenia has been defined as an age related, involuntary loss of skeletal muscle mass and strength. The prevalence of sarcopenia is about 10% globally, and risk factors of sarcopenia includes age, lower physical activity, and malnutrition. Sarcopenia can lead to many adverse health outcomes, particularly in physical and cognitive functions. Most of previous studies have reported that interactive exergame can improve cognitive and physical functions in older population but none of studies use of interactive exergame on older adults with sarcopenia. Therefore, the aim of study will investigate the effects of interactive exergame on older adults with sarcopenia.

Conditions

Sarcopenia

Outcome Measures

Primary Outcomes (8)

• Hand grip

  Dominant hand grip (kg) will measured by a dynamometer. Participants will stand with their arms down by their sides. They will squeeze the dynamometer with maximum isometric effort, which is maintained for 6 seconds. Female less than 18 kg and man less than 28 kg indicate weakness in grip strength.

  Change from Baseline hand grip at Week 12

• Lower limbs strength

  Lower limbs strength will be assessed by the Five Times Sit to Stand. Participants will be asked to sit on the chair with arms folded across their chest, and stand up and sit down as quickly as possible for 5 times. The time (s) to complete the task will be recorded.The time more than 12 seconds indicates weakness in lower limbs strength.

  Change from Baseline lower limbs strength at Week 12

• Appendicular muscle mass

  Appendicular muscle mass will be assessed by the Body Impedance Analysis (BIA).Participants will be asked to stand on the machine and hold the handle of the machine. Female less than 5.7kg/m2 and male less than 7 kg/m2 indicate lower muscle mass.

  Change from Baseline appendicular muscle mass at Week 12

• Function ability

  Function ability test will be determined by the timed up and go test (TUG). Participants will be asked to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down. The times(s) to complete the task will be recorded. Higher than 12s indicate weakness in function ability.

  Change from Baseline function ability at Week 12

• Static balance

  Static balance test will be assessed by the modified Clinical Test for Sensory Interaction in Balance(mCTSIB), The mCTSIB was developed as a clinical version of the Sensory Organization Test and was developed to assesses sensory contributions to postural control. Participants will stand with their hands at their sides, feet together and perform the following 4 sensory conditions: (1) Stand on firm surface with eyes open (2) Stand on firm surface with eyes closed (3) Stand on foam surface with eyes open (4) Stand on foam surface with eyes closed. Each condition will be timed for maximum 30 seconds. The test is terminated when a participant's arms or feet moves. If participants are unable to maintain the position for 30 seconds, they are then provided with 2 additional attempts. The time (s) to complete each condition will be recorded.If they can't complete this test indicate weakness in static balance

  Change from Baseline static balance at Week 12

• Walking ability

  Walking ability test will be measured by the 6 meter walk test. Participant will be asked to walk at their self-selected speed. The time for the middle 6 meters will be recorded and walking speed (m/s) will be calculated.

  Change from Baseline walking ability at Week 12

• Fear of falling

  Fear of falling will be measured by the Falls Efficacy Scale- International (FES-I). The FES-I rates each daily task from "no confident at all" to "completely confident". The total score is between 16 and 64, and the score more than 28 indicates higher level of fear of falling.

  Change from Baseline fear of falling at Week 12

• Cognitive function

  Cognitive function will be evaluated by the Montreal Cognitive Assessment (MoCA), which includes visuospatial abilities, short-term memory recall task, multiple aspects of executive functions, attention, concentration, and working memory. The total score is 30 and the score less than 26 indicates mild cognitive impairment.

  Change from Baseline cognitive function at Week 12

Secondary Outcomes (4)

• Physical Activity

  Change from Baseline physical activity at Week 12

• Diet record

  Change from Baseline diet record at Week 12

• Depression

  Change from Baseline depression at Week 12

• Health-related quality of life

  Change from Baseline health-related quality of life at Week 12

Other Outcomes (2)

• Sarcopenia screening

  Baseline

• Dementia screening

  Baseline

Study Arms (2)

Exergame group

EXPERIMENTAL

The exergame group will receive exergame training for 12 weeks, 2 times a week and 60 min per session.

Other: Interactive Exergame

Control group

NO INTERVENTION

The control group will not receive any intervention and maintain their lifestyle for 12 weeks.

Interventions

Interactive Exergame OTHER

The one-to-one supervised training session consists of 10 min warm-up exercise, 40 min interactive exergame, and 10 min cool-down exercise. Both physical (muscle strength, coordination and balance in lower limbs) and cognitive functions (visuospatial, attention, short-term memory, calculation, reaction and executive function) will be trained through the interactive exergame.

Exergame group

Eligibility Criteria

• Age: 65 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• years old
• able to walk 6 meters without assistance devices
• older adults with possible sarcopenia, sarcopenia or severe sarcopenia

You may not qualify if:

• people with hemodialysis
• people with built-in electronic medical equipment
• people with central nervous system disease such as stroke or Parkinson's disease
• score in ascertain dementia 8 more than 2
• people with mental illness

Sponsors & Collaborators

• Taipei Medical University: lead

Study Sites (1)

Community daycare center

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Shu-Chun Lee, PhD

  School of Gerontology Health Management

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shu-Chun Lee, PhD

CONTACT

0963210548; sclee@tmu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 21, 2021
• First Posted: February 25, 2021
• Study Start: March 9, 2021
• Primary Completion: January 11, 2022
• Study Completion: January 11, 2022
• Last Updated: April 1, 2021

Record last verified: 2021-03

Locations

TW (1)