The Application of the Transtheoretical Model to the Frailty Elderly in the Community

NCT05242549 | Unknown

• 1 other identifier: FJU-IRB NO：C110071
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

As the age structure shows an aging population while facing physical and mental changes among the frailty of the community elderly. Researchers have successively adopted exercise and nutrition strategies for the frail elderly in the community, to improve their physical function, prevent frailty and increase independent functions. There were researches using technology to improve the physical function of the elderly in the community. The transtheoretical model was a comprehensive model of intentional behavior change that incorporates process-oriented variables to explain and predict how and when the elderly change their health behavior including the elderly adoption healthy behavior. Therefore, the investigators use the Trans-Theoretical Model (TTM) to design the "Fitness and Nutrition Program for Seniors" for participants. From improving physical activity and quality of life, then improving the frailty and restoring overall health. The research will be a quasi-experimental design. It is expected to invite 84 frailty elderly from the Community-Based Care Center (42 in the experimental group and 42 in the control group). The investigators use the Trans-Theoretical Model (TTM) as the framework, which includes physical activity training, nutrition education- nursing Information, home-based training, and telecare group care, develop the "Fitness and Nutrition Program for Seniors" for 6 months. The primary outcome includes cardiovascular health study (CHS) frailty criteria, short physical performance battery (SPPB), grip strength, Timed Up and Go Test (TUG), the international physical activity questionnaire (IPAQ), and SF-12. The secondary outcome includes BMI, upper arm and calf circumference to measure nutritional status, short from falls efficacy scale international (FES-I), the visual analog scale (VAS) to measure pain, and instrumental activities of daily living (IADL). The investigator will follow the outcome before the intervention, the third month after the intervention, and the sixth month after the intervention. The collected data were analyzed with a generalized estimation equation model of SPSS version 22. Make the participants develop a habit of physical activity combined with a nutritious diet. Let the elderly reduce frail state, increase physical activity, improve health-related quality of life and improve health-related results.

Conditions

Frailty

Keywords

frailty; community elderly; Transtheoretical Model; Physical Activity; Health-related Quality of Life; nutritious

Outcome Measures

Primary Outcomes (16)

• Basic Demographic Health Assessment Form

  Number, age, gender, education level, marriage, living conditions, tobacco and alcohol use, economic status, chronic illness history

  baseline, pre-intervention(T0)

• Cardiovascular health study (CHS) frailty criteria

  Frailty criteria comprising weak grip of \<26.0 kg in men or \<18.0 kg in women; walking slower than 0.8 m/s; self-reported exhaustion on more than 3 days/week; unintentional weight loss of \>5.0 kg or 10% during the past year; and physical activity \<3.75 MET/h in men or \<2.5 MET/h in women (lowest quintile of sex-specific baseline values). People fulfilling three or more criteria were classed as frail, those who met one or two as prefrail, and those with no such deficits as robust.

  baseline, pre-intervention(T0)

• Cardiovascular health study (CHS) frailty criteria

  Frailty criteria comprising weak grip of \<26.0 kg in men or \<18.0 kg in women; walking slower than 0.8 m/s; self-reported exhaustion on more than 3 days/week; unintentional weight loss of \>5.0 kg or 10% during the past year; and physical activity \<3.75 MET/h in men or \<2.5 MET/h in women (lowest quintile of sex-specific baseline values). People fulfilling three or more criteria were classed as frail, those who met one or two as prefrail, and those with no such deficits as robust.

  three months after intervention(T1)

• Cardiovascular health study (CHS) frailty criteria

  Frailty criteria comprising weak grip of \<26.0 kg in men or \<18.0 kg in women; walking slower than 0.8 m/s; self-reported exhaustion on more than 3 days/week; unintentional weight loss of \>5.0 kg or 10% during the past year; and physical activity \<3.75 MET/h in men or \<2.5 MET/h in women (lowest quintile of sex-specific baseline values). People fulfilling three or more criteria were classed as frail, those who met one or two as prefrail, and those with no such deficits as robust.

  six months after intervention(T2)

• Physical Activity-Short Physical Performance Battery (SPPB)

  SPPB consists of three domains: a Timed 4 m Walk, Balance, and a Chair Sit-to-Stand Test. Each performance measurement was assigned a score from 0 (inability to complete) to 4 (best performance possible). The total of the scores was used to obtain an overall measurement of physical performance. The maximum total score, including all three domains, is 12, and a higher score indicates better physical function.

  baseline, pre-intervention(T0)

• Physical Activity-Short Physical Performance Battery (SPPB)

  SPPB consists of three domains: a Timed 4 m Walk, Balance, and a Chair Sit-to-Stand Test. Each performance measurement was assigned a score from 0 (inability to complete) to 4 (best performance possible). The total of the scores was used to obtain an overall measurement of physical performance. The maximum total score, including all three domains, is 12, and a higher score indicates better physical function.

  three months after intervention(T1)

• Physical Activity-Short Physical Performance Battery (SPPB)

  SPPB consists of three domains: a Timed 4 m Walk, Balance, and a Chair Sit-to-Stand Test. Each performance measurement was assigned a score from 0 (inability to complete) to 4 (best performance possible). The total of the scores was used to obtain an overall measurement of physical performance. The maximum total score, including all three domains, is 12, and a higher score indicates better physical function.

  six months after intervention(T2)

• Physical Activity-Grip Strength

  Grip strength was measured using a dynamometer based on two rounds of measurements for each hand.

  baseline, pre-intervention(T0)

• Physical Activity-Grip Strength

  Grip strength was measured using a dynamometer based on two rounds of measurements for each hand.

  three months after intervention(T1)

• Physical Activity-Grip Strength

  Grip strength was measured using a dynamometer based on two rounds of measurements for each hand.

  six months after intervention(T2)

• Physical Activity-Timed Up and Go Test (TUG)

  Administration of the TUG requires subjects to stand up from a chair, walk 2.44m, turn around, walk back to the chair, and sit down.

  baseline, pre-intervention(T0)

• Physical Activity-Timed Up and Go Test (TUG)

  Administration of the TUG requires subjects to stand up from a chair, walk 2.44m, turn around, walk back to the chair, and sit down.

  three month after intervention(T1)

• Physical Activity-Timed Up and Go Test (TUG)

  Administration of the TUG requires subjects to stand up from a chair, walk 2.44m, turn around, walk back to the chair, and sit down.

  six month after intervention(T2)

• Health-related Quality of Life

  HRQOL was assessed using the Medical Outcomes Survey Short Form-12 questionnaire (SF-12), which consists of eight items representing the following health profile dimensions: general health perception, physical functioning, role functioning-physical, bodily pain, vitality, social functioning, mental health, and role functioning-emotional. Responses are provided using a five- or six-point Likert scale, standardized according to the scoring system. Separate scores are provided for the physical and mental components of health.

  baseline, pre-intervention(T0)

• Health-related Quality of Life

  HRQOL was assessed using the Medical Outcomes Survey Short Form-12 questionnaire (SF-12), which consists of eight items representing the following health profile dimensions: general health perception, physical functioning, role functioning-physical, bodily pain, vitality, social functioning, mental health, and role functioning-emotional. Responses are provided using a five- or six-point Likert scale, standardized according to the scoring system. Separate scores are provided for the physical and mental components of health.

  three months after intervention(T1)

• Health-related Quality of Life

  HRQOL was assessed using the Medical Outcomes Survey Short Form-12 questionnaire (SF-12), which consists of eight items representing the following health profile dimensions: general health perception, physical functioning, role functioning-physical, bodily pain, vitality, social functioning, mental health, and role functioning-emotional. Responses are provided using a five- or six-point Likert scale, standardized according to the scoring system. Separate scores are provided for the physical and mental components of health.

  six months after intervention(T2)

Secondary Outcomes (15)

• kinanthropometric measures-BMI

  baseline, pre-intervention(T0)

• kinanthropometric measures-BMI

  three months after intervention(T1)

• kinanthropometric measures-BMI

  six months after intervention(T2)

• kinanthropometric measures-upper arm and calf circumference

  baseline, pre-intervention(T0)

• kinanthropometric measures-upper arm and calf circumference

  three months after intervention(T1)

Study Arms (2)

Fitness and Nutrition Program for Seniors

EXPERIMENTAL

"Fitness and Nutrition Program for Seniors" includes physical activity training, nutrition education- nursing Information, home-based training, and telecare group care (including APP assistance)

Behavioral: Fitness and Nutrition Program for Seniors

wait-list

NO INTERVENTION

Routine care

Interventions

Fitness and Nutrition Program for Seniors BEHAVIORAL

"Fitness and Nutrition Program for Seniors" uses the Trans-Theoretical Model (TTM) as the framework, which includes physical activity training, nutrition education- nursing Information, home-based training, and telecare group care (including APP assistance). Physical activity training comprised muscle training, joint strengthening, and upper and lower limb resistance exercises for older adults who were frail. After administering nutrition education- nursing Information, participants were encouraged to set their own goals to improve their diet. Home-based training and telecare group care depends on the stages of TTM behavior change of the elderly.

Fitness and Nutrition Program for Seniors

Eligibility Criteria

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

You may qualify if:

• ≥65 years old
• classified as prefrail or frail stage by the Cardiovascular health study (CHS) frailty criteria.
• Conscious clear and can comply with study procedures.
• Have a device that enables online communication, and having the ability to operate this device. (Experimental group)

You may not qualify if:

• Diagnosed as unsuitable for physical activity with high risk of acute and chronic diseases, such as neurological impairment, severe cardiovascular or pulmonary disease, persistent joint pain, or severe musculoskeletal impairment or severe musculoskeletal injury, joint or lower extremity surgery within 6 months.
• severe visual impairment
• institutionalization
• Participated in physical activity or nutrition interventional six months ago

Sponsors & Collaborators

• National Taipei University of Nursing and Health Sciences: lead

Study Sites (1)

Zhiwuyuan and Fujia Community-Based Care Center

Taipei, Shilin Districts, 111, Taiwan

RECRUITING

Related Publications (13)

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• Haider S, Grabovac I, Dorner TE. Effects of physical activity interventions in frail and prefrail community-dwelling people on frailty status, muscle strength, physical performance and muscle mass-a narrative review. Wien Klin Wochenschr. 2019 Jun;131(11-12):244-254. doi: 10.1007/s00508-019-1484-7. Epub 2019 Apr 2.

  PMID: 30941525 BACKGROUND

• Jadczak AD, Makwana N, Luscombe-Marsh N, Visvanathan R, Schultz TJ. Effectiveness of exercise interventions on physical function in community-dwelling frail older people: an umbrella review of systematic reviews. JBI Database System Rev Implement Rep. 2018 Mar;16(3):752-775. doi: 10.11124/JBISRIR-2017-003551.

  PMID: 29521871 BACKGROUND

• Dent E, Lien C, Lim WS, Wong WC, Wong CH, Ng TP, Woo J, Dong B, de la Vega S, Hua Poi PJ, Kamaruzzaman SBB, Won C, Chen LK, Rockwood K, Arai H, Rodriguez-Manas L, Cao L, Cesari M, Chan P, Leung E, Landi F, Fried LP, Morley JE, Vellas B, Flicker L. The Asia-Pacific Clinical Practice Guidelines for the Management of Frailty. J Am Med Dir Assoc. 2017 Jul 1;18(7):564-575. doi: 10.1016/j.jamda.2017.04.018.

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  PMID: 31706592 BACKGROUND

• Li PS, Hsieh CJ, Miao NF, Tsai CH, Liu CY, Lin HR, Wu SV, Koh J. Application of the Fitness and Nutrition Program for Seniors (FANS) to improve Physical Activity and Kinanthropometric Measures among Community-Dwelling Older Adults living with Frailty: a Quasi-experimental Study. BMC Geriatr. 2025 Jul 22;25(1):543. doi: 10.1186/s12877-025-06171-6.

  PMID: 40696284 DERIVED

• Li PS, Hsieh CJ, Miao NF, Tsai CH, Liu CY, Lin HR, Wu SV, Koh J. Enhancing Frailty Status and Health-Related Quality of Life in Community-Dwelling Frail Older Adults. Gerontology. 2025;71(4):273-291. doi: 10.1159/000543909. Epub 2025 Feb 5.

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Related Links

• Reablement and older people, Final report of the International Federation on Aging Copenhagen Summit

MeSH Terms

Conditions

Frailty; Motor Activity

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Chia-Jung Hsieh, PhD

  National Taipei University of Nursing and Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chia-Jung Hsieh, PhD

CONTACT

+886(2)2822-7101; chiajung@ntunhs.edu.tw

Pei-Shan LI, master

CONTACT

+886 920769124; phli2@vghtpe.gov.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, RN, Associate Professor

Study Record Dates

• First Submitted: January 23, 2022
• First Posted: February 16, 2022
• Study Start: June 19, 2022
• Primary Completion: February 28, 2023
• Study Completion: April 1, 2023
• Last Updated: September 30, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)