Clinical trial NCT05279625: Effects of Exercise Interventions in Frail Middle-aged and Older Adults
Official title: Effects of Exercise Interventions in Frail Middle-aged and Older Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Frailty
Keywords: exercise
frailty
physical function
mental function
aged
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2022-03-15
Enrollment: 200
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: a randomized, multi-arm parallel and controlled intervention study.
Primary purpose: TREATMENT

Brief summary: This study aimed to determine the ideal parameters of exercise program for frail middle-aged and older adults on physical and mental functions.

Detailed description: Exercise has been suggested as a possible lifestyle intervention for improving physical and cognitive performance. Various training options depending on various physical circumstances will be presented. However, the ideal exercise protocol for frail middle-aged and older adults had the greater benefits remain unknown. In general, 3-6 months of frequent exercise can enhance physical and cognitive outcome.

The investigators conduct this multiple arm, prospective study to determine the ideal parameters of exercise program for frail middle-aged and older adults on physical and cognitive functions. This study designed to recruit 200 older adults with frailty. All the older adults will receive exercise training using either elastic band, dumbbells, machines, treadmill, cycling for 6 months. Outcome measures including a systematic evaluation for frail older persons using comprehensive geriatric assessment, as well as the assessments of physical and cognitive functions before and after interventions.

Eligibility criteria: Inclusion Criteria:

* Patients aged above 50 years old with frailty syndrome

Exclusion Criteria:

* Acute illnesses, such as unstable cardiac dysrhythmia, sepsis, or unstable vital signs
* Physical or Cognitive issues that make it difficult for the patients to participate in our program

Primary outcomes:
measure: Change of Barthel index
timeFrame: Up to 6 months
measure: Change of Montreal Cognitive Assessment
timeFrame: Up to 6 months
measure: Change of Geriatric Depression Scale
timeFrame: Up to 6 months
measure: Change of Lawton Instrumental Activities of Daily Living (IADL) Scale
timeFrame: Up to 6 months
Secondary outcomes:
measure: Change of Six-minute Walking Test
timeFrame: Up to 6 months
measure: Change of Timed Get-up-and-go Test
timeFrame: Up to 6 months
measure: Change of Memory span test
timeFrame: Up to 6 months
measure: Change of Color Trails Test
timeFrame: Up to 6 months
measure: Change of Digit symbol substitution test
timeFrame: Up to 6 months
measure: Change of Mini-mental state examination
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Yilan
country: Taiwan
facility: Department of Physical Medicine & Rehabilitation, Taipei Veterans General Hospital, Yuan-Shan/Su-Ao Branch
Study officials:
affiliation: Taipei Veterans General Hospital, Yuan-Shan/Su-Ao Branch, Yilan, Taiwan
name: Wang-Sheng Lin, MD
role: PRINCIPAL_INVESTIGATOR
References: