跳至主要内容
临床试验/NCT05242549
NCT05242549招募中不适用

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

National Taipei University of Nursing and Health Sciences1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2022年6月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
84
试验地点
1
主要终点
Physical Activity-Grip Strength

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
65 Years 至 99 Years(Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •≥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)

排除标准

  • •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

研究组 & 干预措施

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)

干预措施: Fitness and Nutrition Program for Seniors (Behavioral)

wait-list

No Intervention

Routine care

结局指标

主要结局

Physical Activity-Grip Strength

时间窗: 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)

时间窗: 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.

Basic Demographic Health Assessment Form

时间窗: 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

时间窗: 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)

时间窗: 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.

Health-related Quality of Life

时间窗: 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.

Cardiovascular health study (CHS) frailty criteria

时间窗: 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

时间窗: 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.

Physical Activity-Timed Up and Go Test (TUG)

时间窗: 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-Short Physical Performance Battery (SPPB)

时间窗: 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)

时间窗: 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-Grip Strength

时间窗: baseline, pre-intervention(T0)

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

Physical Activity-Grip Strength

时间窗: three months after intervention(T1)

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

Physical Activity-Timed Up and Go Test (TUG)

时间窗: 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.

Health-related Quality of Life

时间窗: 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

时间窗: 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.

次要结局

  • kinanthropometric measures-BMI(six months after intervention(T2))
  • kinanthropometric measures-upper arm and calf circumference(six months after intervention(T2))
  • the visual analog scale (VAS) to measure pain(six months after intervention(T2))
  • Instrumental activities of daily living (IADL)(six months after intervention(T2))
  • short from falls efficacy scale international (FES-I)(six months after intervention(T2))
  • kinanthropometric measures-BMI(baseline, pre-intervention(T0))
  • kinanthropometric measures-BMI(three months after intervention(T1))
  • kinanthropometric measures-upper arm and calf circumference(baseline, pre-intervention(T0))
  • kinanthropometric measures-upper arm and calf circumference(three months after intervention(T1))
  • short from falls efficacy scale international (FES-I)(baseline, pre-intervention(T0))
  • short from falls efficacy scale international (FES-I)(three months after intervention(T1))
  • the visual analog scale (VAS) to measure pain(baseline, pre-intervention(T0))
  • the visual analog scale (VAS) to measure pain(three months after intervention(T1))
  • Instrumental activities of daily living (IADL)(baseline, pre-intervention(T0))
  • Instrumental activities of daily living (IADL)(three months after intervention(T1))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Chia Jung Hsieh

PhD, RN, Associate Professor

National Taipei University of Nursing and Health Sciences

研究点 (1)

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