FrailtyNCT05242549
The Application of the Transtheoretical Model to the Frailty Elderly in the Community
A study testing Fitness and Nutrition Program for Seniors in people with Frailty, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Frailty
- What is being tested?
- Fitness and Nutrition Program for Seniors
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteTaiwan
- Study dates
- 19 Jun 2022to 1 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 99 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- ≥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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Zhiwuyuan and Fujia Community-Based Care Center
Taipei, Shilin Districts, 111
Chunmin Liao, Undertaker, +886 228342158
Wenzong Xiao, Undertaker, +886 228350489
About this study
Official title: Application of the Transtheoretical Model to Physical Activity and Health-related Quality of Life Among the Frailty of the Community Elderly
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.
Read the detailed description
The ageing population of the world is an irreversible international situation because of the rapidly increasing number of elderly populations in the 21st century. As the age structure shows an aging population while facing physical and mental changes among the frailty of the community elderly. Helping them prevent disability and promote health has become the focus of current care. 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. The internet was a simple and fast model to care elderly in the community. 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, which includes Home-Based physical activity training, nutrition education, and telecare technology. The investigator use the Trans-Theoretical Model (TTM) to analyze the behavior change process of the participants and to explore important factors during the intervention. From improving physical activity and quality of life, then improving the frailty and restoring overall health.
The research will be a quasi-experimental pretest-posttest design. It is expected to invite 84 frailty elderly from Community-Based Care Center in Shilin Districts in Taipei City, Taiwan (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, developing the "Fitness and Nutrition Program for Seniors" for 6 months for community-dwelling frail older adults. The participants create motivation to start execution through physical activity and nutritional knowledge and provide the experimental group with online home-based training from the three different stages of TTM behavior change. During the intervention period, the investigators will follow the adherence, satisfaction, behavior change stage every month. The investigators use motivation to improve the self-efficacy of the participants and achieve the result of behavior change. Finally, support the frail participants to enter the maintenance phase. The primary outcome includes frailty status (cardiovascular health study (CHS) frailty criteria), Physical Activity (short physical performance battery (SPPB), grip strength, Timed Up and Go Test (TUG), the international physical activity questionnaire (IPAQ)), and Health-related Quality of Life (SF-12). The secondary outcome includes kinanthropometric measures (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 investigators 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. The research hopes to promote the health of the frailty participants through FANS in the community. Make the participants develop a habit of physical activity combined with a nutritious diet. Let the participants reduce frail state, increase physical activity, improve health-related quality of life and improve health-related results, and have a healthy life.
- Conditions
- Frailty
- Being tested
- Fitness and Nutrition Program for Seniors
- Keywords
- frailty, community elderly, Transtheoretical Model, Physical Activity, Health-related Quality of Life, nutritious
- Medical subject headings
- Frailty, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fitness and Nutrition Program for SeniorsBehavioural
"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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Behavioral: Fitness and Nutrition Program for Seniors |
| wait-list | No intervention | Routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Basic Demographic Health Assessment Form
Number, age, gender, education level, marriage, living conditions, tobacco and alcohol use, economic status, chronic illness history
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline, pre-intervention(T0)
Physical Activity-Grip Strength
Grip strength was measured using a dynamometer based on two rounds of measurements for each hand.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: six months after intervention(T2)
Secondary outcomes (15)
kinanthropometric measures-BMI
Body mass index (BMI) is a measure of body fat based on height and weight that applies to adult men and women. We use weight and height will be combined to report BMI in kg/m2.
Measured: baseline, pre-intervention(T0)
kinanthropometric measures-BMI
Body mass index (BMI) is a measure of body fat based on height and weight that applies to adult men and women. We use weight and height will be combined to report BMI in kg/m2.
Measured: three months after intervention(T1)
kinanthropometric measures-BMI
Body mass index (BMI) is a measure of body fat based on height and weight that applies to adult men and women. We use weight and height will be combined to report BMI in kg/m2.
Measured: six months after intervention(T2)
kinanthropometric measures-upper arm and calf circumference
Upper arm and calf circumference were measured to the nearest 0.1 cm using a flexible but nonstretch measuring tape. Upper arm and calf circumference to measure nutritional status
Measured: baseline, pre-intervention(T0)
kinanthropometric measures-upper arm and calf circumference
Upper arm and calf circumference were measured to the nearest 0.1 cm using a flexible but nonstretch measuring tape. Upper arm and calf circumference to measure nutritional status
Measured: three months after intervention(T1)
kinanthropometric measures-upper arm and calf circumference
Upper arm and calf circumference were measured to the nearest 0.1 cm using a flexible but nonstretch measuring tape. Upper arm and calf circumference to measure nutritional status
Measured: six months after intervention(T2)
short from falls efficacy scale international (FES-I)
The 7 items of the FES-I were rated on a 4-point Likert scale with the following possible answers (scores in parentheses): ''not at all'' (1); ''somewhat'' (2); 'fairly' (3); and 'very concerned' (4). If subjects were unable to perform the activity, they were encouraged to respond hypothetically. The range of possible total scores was from 7 to 28, with a high score indicating greater fear of falling.
Measured: baseline, pre-intervention(T0)
short from falls efficacy scale international (FES-I)
The 7 items of the FES-I were rated on a 4-point Likert scale with the following possible answers (scores in parentheses): ''not at all'' (1); ''somewhat'' (2); 'fairly' (3); and 'very concerned' (4). If subjects were unable to perform the activity, they were encouraged to respond hypothetically. The range of possible total scores was from 7 to 28, with a high score indicating greater fear of falling.
Measured: three months after intervention(T1)
short from falls efficacy scale international (FES-I)
The 7 items of the FES-I were rated on a 4-point Likert scale with the following possible answers (scores in parentheses): ''not at all'' (1); ''somewhat'' (2); 'fairly' (3); and 'very concerned' (4). If subjects were unable to perform the activity, they were encouraged to respond hypothetically. The range of possible total scores was from 7 to 28, with a high score indicating greater fear of falling.
Measured: six months after intervention(T2)
the visual analog scale (VAS) to measure pain
ranging from "no pain= 0mm" to "unwilling pain= 100mm". Scores were calculated to the nearest millimetre with a ruler.
Measured: baseline, pre-intervention(T0)
the visual analog scale (VAS) to measure pain
ranging from "no pain= 0mm" to "unwilling pain= 100mm". Scores were calculated to the nearest millimetre with a ruler.
Measured: three months after intervention(T1)
the visual analog scale (VAS) to measure pain
ranging from "no pain= 0mm" to "unwilling pain= 100mm". Scores were calculated to the nearest millimetre with a ruler.
Measured: six months after intervention(T2)
Instrumental activities of daily living (IADL)
IADL is a 15-item questionnaire that assesses recent participation in functional activity. For each item, participants are required to indicate the extent which four statements reflect their recent participation in an activity. Although responses regarding the four statements varied between items, scores generally ranged from 0 ("never") to 3 ("most days" or "at least once weekly"). Total scores, calculated by summing the item scores, range from 0 to 45.
Measured: baseline, pre-intervention(T0)
Instrumental activities of daily living (IADL)
IADL is a 15-item questionnaire that assesses recent participation in functional activity. For each item, participants are required to indicate the extent which four statements reflect their recent participation in an activity. Although responses regarding the four statements varied between items, scores generally ranged from 0 ("never") to 3 ("most days" or "at least once weekly"). Total scores, calculated by summing the item scores, range from 0 to 45.
Measured: three months after intervention(T1)
Instrumental activities of daily living (IADL)
IADL is a 15-item questionnaire that assesses recent participation in functional activity. For each item, participants are required to indicate the extent which four statements reflect their recent participation in an activity. Although responses regarding the four statements varied between items, scores generally ranged from 0 ("never") to 3 ("most days" or "at least once weekly"). Total scores, calculated by summing the item scores, range from 0 to 45.
Measured: six months after intervention(T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2022
- Study start19 Jun 2022
- Primary completion28 Feb 2023 (estimated)
- Study completion1 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for FrailtyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taipei University of Nursing and Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chia Jung Hsieh, National Taipei University of Nursing and Health Sciences
- Investigators
- Chia-Jung Hsieh, PhD, Principal investigator, National Taipei University of Nursing and Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05242549
- Sponsor's protocol ID
- FJU-IRB NO：C110071
- Status last verified
- Sep 2022
- First submitted
- 23 Jan 2022
- Last updated
- 30 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Barton AC, Sheen J, Byrne LK. Immediate Attention Enhancement and Restoration From Interactive and Immersive Technologies: A Scoping Review. Front Psychol. 2020 Aug 19;11:2050. doi: 10.3389/fpsyg.2020.02050. eCollection 2020.
PubMed 32973620Gerotziafas GT, Catalano M, Theodorou Y, Dreden PV, Marechal V, Spyropoulos AC, Carter C, Jabeen N, Harenberg J, Elalamy I, Falanga A, Fareed J, Agathaggelou P, Antic D, Antignani PL, Bosch MM, Brenner B, Chekhonin V, Colgan MP, Dimopoulos MA, Douketis J, Elnazar EA, Farkas K, Fazeli B, Fowkes G, Gu Y, Gligorov J, Ligocki MA, Indran T, Kannan M, Kantarcioglu B, Kasse AA, Konstantinidis K, Leivano F, Lewis J, Makatsariya A, Mbaye PM, Mahe I, Panovska-Stavridis I, Olinic DM, Papageorgiou C, Pecsvarady Z, Pillon S, Ramacciotti E, Abdel-Razeq H, Sabbah M, Sassi M, Schernthaner G, Siddiqui F, Shiomura J, Slama-Schwok A, Wautrecht JC, Tafur A, Taher A, Klein-Wegel P, Zhai Z, Zoubida TM; Scientific Reviewer Committee. The COVID-19 Pandemic and the Need for an Integrated and Equitable Approach: An International Expert Consensus Paper. Thromb Haemost. 2021 Aug;121(8):992-1007. doi: 10.1055/a-1535-8807. Epub 2021 Jul 20.
PubMed 34169495Haider 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.
PubMed 30941525Jadczak 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.
PubMed 29521871Dent 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.
PubMed 28648901Marston HR, Shore L, White PJ. How does a (Smart) Age-Friendly Ecosystem Look in a Post-Pandemic Society? Int J Environ Res Public Health. 2020 Nov 9;17(21):8276. doi: 10.3390/ijerph17218276.
PubMed 33182413Nagai K, Miyamato T, Okamae A, Tamaki A, Fujioka H, Wada Y, Uchiyama Y, Shinmura K, Domen K. Physical activity combined with resistance training reduces symptoms of frailty in older adults: A randomized controlled trial. Arch Gerontol Geriatr. 2018 May-Jun;76:41-47. doi: 10.1016/j.archger.2018.02.005. Epub 2018 Feb 13.
PubMed 29455058Kidd T, Mold F, Jones C, Ream E, Grosvenor W, Sund-Levander M, Tingstrom P, Carey N. What are the most effective interventions to improve physical performance in pre-frail and frail adults? A systematic review of randomised control trials. BMC Geriatr. 2019 Jul 11;19(1):184. doi: 10.1186/s12877-019-1196-x.
PubMed 31291884Wang L, Chen H, Lu H, Wang Y, Liu C, Dong X, Chen J, Liu N, Yu F, Wan Q, Shang S. The effect of transtheoretical model-lead intervention for knee osteoarthritis in older adults: a cluster randomized trial. Arthritis Res Ther. 2020 Jun 8;22(1):134. doi: 10.1186/s13075-020-02222-y.
PubMed 32513273Zazzara MB, Vetrano DL, Carfi A, Onder G. Frailty and chronic disease. Panminerva Med. 2019 Dec;61(4):486-492. doi: 10.23736/S0031-0808.19.03731-5. Epub 2019 Jul 30.
PubMed 31362483Zhang Y, Zhang Y, Du S, Wang Q, Xia H, Sun R. Exercise interventions for improving physical function, daily living activities and quality of life in community-dwelling frail older adults: A systematic review and meta-analysis of randomized controlled trials. Geriatr Nurs. 2020 May-Jun;41(3):261-273. doi: 10.1016/j.gerinurse.2019.10.006. Epub 2019 Nov 6.
PubMed 31706592Li 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.
PubMed 40696284Li 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.
PubMed 40552877
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of the Transtheoretical Model to Physical Activity and Health-related Quality of Life Among the Frailty of the Community Elderly
- ClinicalTrials.gov ID
- NCT05242549
- Acronym / sponsor ID
- FJU-IRB NO：C110071
- Conditions
- Frailty
- Keywords
- frailty, community elderly, Transtheoretical Model, Physical Activity, Health-related Quality of Life, nutritious
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- National Taipei University of Nursing and Health SciencesUniversity, hospital or other
- Study start
- 19 Jun 2022 (actual)
- Primary completion
- 28 Feb 2023 (estimated)
- Study completion
- 1 Apr 2023 (estimated)
- First posted
- 16 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The ageing population of the world is an irreversible international situation because of the rapidly increasing number of elderly populations in the 21st century. As the age structure shows an aging population while facing physical and mental changes among the frailty of the community elderly. Helping them prevent disability and promote health has become the focus of current care. 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. The internet was a simple and fast model to care elderly in the community. 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, which includes Home-Based physical activity training, nutrition education, and telecare technology. The investigator use the Trans-Theoretical Model (TTM) to analyze the behavior change process of the participants and to explore important factors during the intervention. From improving physical activity and quality of life, then improving the frailty and restoring overall health.
The research will be a quasi-experimental pretest-posttest design. It is expected to invite 84 frailty elderly from Community-Based Care Center in Shilin Districts in Taipei City, Taiwan (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, developing the "Fitness and Nutrition Program for Seniors" for 6 months for community-dwelling frail older adults. The participants create motivation to start execution through physical activity and nutritional knowledge and provide the experimental group with online home-based training from the three different stages of TTM behavior change. During the intervention period, the investigators will follow the adherence, satisfaction, behavior change stage every month. The investigators use motivation to improve the self-efficacy of the participants and achieve the result of behavior change. Finally, support the frail participants to enter the maintenance phase. The primary outcome includes frailty status (cardiovascular health study (CHS) frailty criteria), Physical Activity (short physical performance battery (SPPB), grip strength, Timed Up and Go Test (TUG), the international physical activity questionnaire (IPAQ)), and Health-related Quality of Life (SF-12). The secondary outcome includes kinanthropometric measures (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 investigators 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. The research hopes to promote the health of the frailty participants through FANS in the community. Make the participants develop a habit of physical activity combined with a nutritious diet. Let the participants reduce frail state, increase physical activity, improve health-related quality of life and improve health-related results, and have a healthy life.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fitness and Nutrition Program for Seniors | Experimental | Behavioral: Fitness and Nutrition Program for Seniors"Fitness and Nutrition Program for Seniors" includes physical activity training, nutrition education- nursing Information, home-based training, and telecare group care (including APP assistance) |
| wait-list | No intervention | –Routine care |
Who may qualify
- Ages
- 65 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- ≥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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fitness and Nutrition Program for Seniors"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. | Behavioural | Fitness and Nutrition Program for Seniors |
Primary outcome
Basic Demographic Health Assessment Form
Time frame: baseline, pre-intervention(T0)
Number, age, gender, education level, marriage, living conditions, tobacco and alcohol use, economic status, chronic illness history
Cardiovascular health study (CHS) frailty criteria
Time frame: baseline, pre-intervention(T0)
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.
Cardiovascular health study (CHS) frailty criteria
Time frame: three months after intervention(T1)
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.
Cardiovascular health study (CHS) frailty criteria
Time frame: six months after intervention(T2)
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.
Physical Activity-Short Physical Performance Battery (SPPB)
Time frame: baseline, pre-intervention(T0)
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.
Physical Activity-Short Physical Performance Battery (SPPB)
Time frame: three months after intervention(T1)
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.
Physical Activity-Short Physical Performance Battery (SPPB)
Time frame: six months after intervention(T2)
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.
Physical Activity-Grip Strength
Time frame: baseline, pre-intervention(T0)
Grip strength was measured using a dynamometer based on two rounds of measurements for each hand.
Physical Activity-Grip Strength
Time frame: three months after intervention(T1)
Grip strength was measured using a dynamometer based on two rounds of measurements for each hand.
Physical Activity-Grip Strength
Time frame: six months after intervention(T2)
Grip strength was measured using a dynamometer based on two rounds of measurements for each hand.
Physical Activity-Timed Up and Go Test (TUG)
Time frame: baseline, pre-intervention(T0)
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.
Physical Activity-Timed Up and Go Test (TUG)
Time frame: three month after intervention(T1)
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.
Physical Activity-Timed Up and Go Test (TUG)
Time frame: six month after intervention(T2)
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.
Health-related Quality of Life
Time frame: baseline, pre-intervention(T0)
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.
Health-related Quality of Life
Time frame: three months after intervention(T1)
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.
Health-related Quality of Life
Time frame: six months after intervention(T2)
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.
15 secondary outcomes
kinanthropometric measures-BMI
Time frame: baseline, pre-intervention(T0)
kinanthropometric measures-BMI
Time frame: three months after intervention(T1)
kinanthropometric measures-BMI
Time frame: six months after intervention(T2)
kinanthropometric measures-upper arm and calf circumference
Time frame: baseline, pre-intervention(T0)
kinanthropometric measures-upper arm and calf circumference
Time frame: three months after intervention(T1)
kinanthropometric measures-upper arm and calf circumference
Time frame: six months after intervention(T2)
short from falls efficacy scale international (FES-I)
Time frame: baseline, pre-intervention(T0)
short from falls efficacy scale international (FES-I)
Time frame: three months after intervention(T1)
short from falls efficacy scale international (FES-I)
Time frame: six months after intervention(T2)
the visual analog scale (VAS) to measure pain
Time frame: baseline, pre-intervention(T0)
the visual analog scale (VAS) to measure pain
Time frame: three months after intervention(T1)
the visual analog scale (VAS) to measure pain
Time frame: six months after intervention(T2)
Instrumental activities of daily living (IADL)
Time frame: baseline, pre-intervention(T0)
Instrumental activities of daily living (IADL)
Time frame: three months after intervention(T1)
Instrumental activities of daily living (IADL)
Time frame: six months after intervention(T2)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2022.
- Background: PubMed 32973620Barton AC, Sheen J, Byrne LK. Immediate Attention Enhancement and Restoration From Interactive and Immersive Technologies: A Scoping Review. Front Psychol. 2020 Aug 19;11:2050. doi: 10.3389/fpsyg.2020.02050. eCollection 2020.
- Background: PubMed 34169495Gerotziafas GT, Catalano M, Theodorou Y, Dreden PV, Marechal V, Spyropoulos AC, Carter C, Jabeen N, Harenberg J, Elalamy I, Falanga A, Fareed J, Agathaggelou P, Antic D, Antignani PL, Bosch MM, Brenner B, Chekhonin V, Colgan MP, Dimopoulos MA, Douketis J, Elnazar EA, Farkas K, Fazeli B, Fowkes G, Gu Y, Gligorov J, Ligocki MA, Indran T, Kannan M, Kantarcioglu B, Kasse AA, Konstantinidis K, Leivano F, Lewis J, Makatsariya A, Mbaye PM, Mahe I, Panovska-Stavridis I, Olinic DM, Papageorgiou C, Pecsvarady Z, Pillon S, Ramacciotti E, Abdel-Razeq H, Sabbah M, Sassi M, Schernthaner G, Siddiqui F, Shiomura J, Slama-Schwok A, Wautrecht JC, Tafur A, Taher A, Klein-Wegel P, Zhai Z, Zoubida TM; Scientific Reviewer Committee. The COVID-19 Pandemic and the Need for an Integrated and Equitable Approach: An International Expert Consensus Paper. Thromb Haemost. 2021 Aug;121(8):992-1007. doi: 10.1055/a-1535-8807. Epub 2021 Jul 20.
- Background: PubMed 30941525Haider 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.
- Background: PubMed 29521871Jadczak 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.
- Background: PubMed 28648901Dent 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.
- Background: PubMed 33182413Marston HR, Shore L, White PJ. How does a (Smart) Age-Friendly Ecosystem Look in a Post-Pandemic Society? Int J Environ Res Public Health. 2020 Nov 9;17(21):8276. doi: 10.3390/ijerph17218276.
- Background: PubMed 29455058Nagai K, Miyamato T, Okamae A, Tamaki A, Fujioka H, Wada Y, Uchiyama Y, Shinmura K, Domen K. Physical activity combined with resistance training reduces symptoms of frailty in older adults: A randomized controlled trial. Arch Gerontol Geriatr. 2018 May-Jun;76:41-47. doi: 10.1016/j.archger.2018.02.005. Epub 2018 Feb 13.
- Background: PubMed 31291884Kidd T, Mold F, Jones C, Ream E, Grosvenor W, Sund-Levander M, Tingstrom P, Carey N. What are the most effective interventions to improve physical performance in pre-frail and frail adults? A systematic review of randomised control trials. BMC Geriatr. 2019 Jul 11;19(1):184. doi: 10.1186/s12877-019-1196-x.
- Background: PubMed 32513273Wang L, Chen H, Lu H, Wang Y, Liu C, Dong X, Chen J, Liu N, Yu F, Wan Q, Shang S. The effect of transtheoretical model-lead intervention for knee osteoarthritis in older adults: a cluster randomized trial. Arthritis Res Ther. 2020 Jun 8;22(1):134. doi: 10.1186/s13075-020-02222-y.
- Background: PubMed 31362483Zazzara MB, Vetrano DL, Carfi A, Onder G. Frailty and chronic disease. Panminerva Med. 2019 Dec;61(4):486-492. doi: 10.23736/S0031-0808.19.03731-5. Epub 2019 Jul 30.
- Background: PubMed 31706592Zhang Y, Zhang Y, Du S, Wang Q, Xia H, Sun R. Exercise interventions for improving physical function, daily living activities and quality of life in community-dwelling frail older adults: A systematic review and meta-analysis of randomized controlled trials. Geriatr Nurs. 2020 May-Jun;41(3):261-273. doi: 10.1016/j.gerinurse.2019.10.006. Epub 2019 Nov 6.
- Derived from this study: PubMed 40696284Li 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.
- Reablement and older people, Final report of the International Federation on Aging Copenhagen SummitLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chia-Jung Hsieh, PhD principal investigator
National Taipei University of Nursing and Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fitness and Nutrition Program for Seniors in people with Frailty, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chia-Jung Hsieh, PhD (+886(2)2822-7101 ext. 3135, chiajung@ntunhs.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Basic Demographic Health Assessment Form (time frame: baseline, pre-intervention(T0)). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05242549, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2022.