Clinical trial NCT05242549: The Application of the Transtheoretical Model to the Frailty Elderly in the Community
Official title: Application of the Transtheoretical Model to Physical Activity and Health-related Quality of Life Among the Frailty of the Community Elderly
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Frailty
Keywords: frailty
community elderly
Transtheoretical Model
Physical Activity
Health-related Quality of Life
nutritious
Lead sponsor: National Taipei University of Nursing and Health Sciences
Sponsor class: OTHER
First posted: 2022-02-16
Enrollment: 84
Sex: ALL
Minimum age (years): 65
Maximum age (years): 99
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Basic Demographic Health Assessment Form
timeFrame: baseline, pre-intervention(T0)
measure: Cardiovascular health study (CHS) frailty criteria
timeFrame: baseline, pre-intervention(T0)
measure: Cardiovascular health study (CHS) frailty criteria
timeFrame: three months after intervention(T1)
measure: Cardiovascular health study (CHS) frailty criteria
timeFrame: six months after intervention(T2)
measure: Physical Activity-Short Physical Performance Battery (SPPB)
timeFrame: baseline, pre-intervention(T0)
measure: Physical Activity-Short Physical Performance Battery (SPPB)
timeFrame: three months after intervention(T1)
measure: Physical Activity-Short Physical Performance Battery (SPPB)
timeFrame: six months after intervention(T2)
measure: Physical Activity-Grip Strength
timeFrame: baseline, pre-intervention(T0)
measure: Physical Activity-Grip Strength
timeFrame: three months after intervention(T1)
measure: Physical Activity-Grip Strength
timeFrame: six months after intervention(T2)
measure: Physical Activity-Timed Up and Go Test (TUG)
timeFrame: baseline, pre-intervention(T0)
measure: Physical Activity-Timed Up and Go Test (TUG)
timeFrame: three month after intervention(T1)
measure: Physical Activity-Timed Up and Go Test (TUG)
timeFrame: six month after intervention(T2)
measure: Health-related Quality of Life
timeFrame: baseline, pre-intervention(T0)
measure: Health-related Quality of Life
timeFrame: three months after intervention(T1)
measure: Health-related Quality of Life
timeFrame: six months after intervention(T2)
Secondary outcomes:
measure: kinanthropometric measures-BMI
timeFrame: baseline, pre-intervention(T0)
measure: kinanthropometric measures-BMI
timeFrame: three months after intervention(T1)
measure: kinanthropometric measures-BMI
timeFrame: six months after intervention(T2)
measure: kinanthropometric measures-upper arm and calf circumference
timeFrame: baseline, pre-intervention(T0)
measure: kinanthropometric measures-upper arm and calf circumference
timeFrame: three months after intervention(T1)
measure: kinanthropometric measures-upper arm and calf circumference
timeFrame: six months after intervention(T2)
measure: short from falls efficacy scale international (FES-I)
timeFrame: baseline, pre-intervention(T0)
measure: short from falls efficacy scale international (FES-I)
timeFrame: three months after intervention(T1)
measure: short from falls efficacy scale international (FES-I)
timeFrame: six months after intervention(T2)
measure: the visual analog scale (VAS) to measure pain
timeFrame: baseline, pre-intervention(T0)
measure: the visual analog scale (VAS) to measure pain
timeFrame: three months after intervention(T1)
measure: the visual analog scale (VAS) to measure pain
timeFrame: six months after intervention(T2)
measure: Instrumental activities of daily living (IADL)
timeFrame: baseline, pre-intervention(T0)
measure: Instrumental activities of daily living (IADL)
timeFrame: three months after intervention(T1)
measure: Instrumental activities of daily living (IADL)
timeFrame: six months after intervention(T2)
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Zhiwuyuan and Fujia Community-Based Care Center
state: Shilin Districts
Study officials:
affiliation: National Taipei University of Nursing and Health Sciences
name: Chia-Jung Hsieh, PhD
role: PRINCIPAL_INVESTIGATOR
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