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

Frailty Clinical Trial

Official title:

Application of the Transtheoretical Model to Physical Activity and Health-related Quality of Life Among the Frailty of the Community Elderly

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05242549
• Other study ID #: FJU-IRB NO:C110071
• Status: Recruiting
• Phase: N/A
• Start date: June 19, 2022
• Est. completion date: April 1, 2023

Study information

• Verified date: September 2022
• Source: National Taipei University of Nursing and Health Sciences
• Contact: Chia-Jung Hsieh, PhD
• Phone: +886(2)2822-7101
• Email: chiajung[@]ntunhs.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: April 1, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 99 Years

Eligibility

Inclusion Criteria:

1. =65 years old

2. classified as prefrail or frail stage by the Cardiovascular health study (CHS) frailty criteria.

3. Conscious clear and can comply with study procedures.

4. Have a device that enables online communication, and having the ability to operate this device. (Experimental group)

Exclusion Criteria:

1. 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.

2. severe visual impairment

3. institutionalization

4. Participated in physical activity or nutrition interventional six months ago

Related Conditions & MeSH terms

• Frailty

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Taiwan	Zhiwuyuan and Fujia Community-Based Care Center	Taipei	Shilin Districts

Sponsors (1)

Lead Sponsor	Collaborator
National Taipei University of Nursing and Health Sciences

Country where clinical trial is conducted

Taiwan, 

References & Publications (11)

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Gerotziafas 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, Mahé 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. — View Citation

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. Review. — View Citation

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. — View Citation

Kidd T, Mold F, Jones C, Ream E, Grosvenor W, Sund-Levander M, Tingström 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. — View Citation

Marston 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). pii: E8276. doi: 10.3390/ijerph17218276. — View Citation

Nagai 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. — View Citation

Wang 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. — View Citation

Zazzara MB, Vetrano DL, Carfì 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. Review. — View Citation

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* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	Physical Activity-Grip Strength	Grip strength was measured using a dynamometer based on two rounds of measurements for each hand.	baseline, pre-intervention(T0)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	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.	baseline, pre-intervention(T0)
Secondary	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.	three months after intervention(T1)
Secondary	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.	six months after intervention(T2)
Secondary	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	baseline, pre-intervention(T0)
Secondary	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	three months after intervention(T1)
Secondary	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	six months after intervention(T2)
Secondary	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.	baseline, pre-intervention(T0)
Secondary	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.	three months after intervention(T1)
Secondary	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.	six months after intervention(T2)
Secondary	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.	baseline, pre-intervention(T0)
Secondary	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.	three months after intervention(T1)
Secondary	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.	six months after intervention(T2)
Secondary	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.	baseline, pre-intervention(T0)
Secondary	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.	three months after intervention(T1)
Secondary	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.	six months after intervention(T2)

External Links

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