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临床试验/NCT07085884
NCT07085884已完成不适用

A Comprehensive Intervention Program of Static-dynamic Balance Training Combined With Reminiscence Therapy on the Level of Healthy Aging Among Older Adults in a Rural Community

Xinyu Yang1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2023年5月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
64
试验地点
1
主要终点
The Healthy Aging Instrument (HAI)

研究概览

简要总结

The SDBT-RT Program: A Holistic Approach for Rural Older Adults We developed the Static-Dynamic Balance Training Combined with Reminiscence Therapy (SDBT-RT) program to help older adults in rural communities adopt healthier habits. This program is rooted in the Theory of Planned Behavior , which emphasizes how attitudes, social norms, and perceived control influence behavior. It was designed specifically for rural contexts, considering local policies, lifestyle habits, social networks, and individual needs.

Key Components Expert Review & Pilot Testing Before launching, the program was refined by 5 experts in sports rehabilitation, medical psychology, geriatrics, health management, and nursing. A pilot study was conducted to ensure feasibility.

Static-Dynamic Balance Training (SDBT)

This physical training aims to improve stability and reduce fall risks. It includes:

10-Minute Warm-Up: Stretching wrists, hips, shoulders, knees, and ankles. 15-Minute Static Balance: Standing on both feet, tandem stance, and single-leg balance.

25-Minute Dynamic Balance: Walking normally, on narrow paths, and in tandem. Difficulty increases gradually with sensory challenges (e.g., distractions) and real-time guidance to build confidence .

Reminiscence Therapy (RT)

Based on Erikson's theory of psychosocial development , RT helps older adults reflect on life experiences to achieve psychological "integrity" (acceptance of life) over despair. Six structured themes guide discussions:

"Our Time," "My Happy Times," "Life Achievements," "Traditional Festivals," "My Hobbies," and "Nostalgic Memories." These activities foster optimism and self-acceptance, aligned with rural Chinese cultural practices .

Implementation Details Trained Staff: General practitioners, community health workers, and medical students underwent 1 month of training to lead sessions.

Group Structure: 32 participants were divided into 8-person groups and met at community centers (with multimedia facilities and green spaces) from 8:00-10:00 AM to align with their routines.

12-Week Intervention: Odd-Numbered Weeks: 40-minute RT + 50-minute SDBT. RT strengthens motivation (attitudes/norms), while SDBT improves physical control.

Even-Numbered Weeks: 50-minute SDBT only, focusing on skill mastery without cognitive overload.

Monitoring:

Observation Checklists and feedback forms tracked engagement and emotions. Implementation Fidelity Checklists ensured sessions followed protocols. Supervisors reviewed 20% of checklists weekly .

Behavior Log Forms recorded participants' health behaviors (e.g., supplement use, illnesses) to identify confounding factors.

Follow-Up: After the 12 weeks, participants received 4 weekly phone calls (5-10 minutes) to encourage home practice and address questions.

Safety & Adaptability Facilitators were trained to recognize fatigue or distress and adjust activities as needed.

Emergency protocols addressed physical/psychological incidents. Absent participants were contacted for makeup sessions, and adherence was prioritized.

This program integrates psychological reflection and physical training to empower rural older adults, fostering both mental well-being and functional independence. By tailoring interventions to local contexts and using evidence-based theories, SDBT-RT aims to create sustainable behavior change.

详细描述

The Static-Dynamic Balance Training Combined with Reminiscence Therapy (SDBT-RT) program, grounded in the Theory of Planned Behavior, was designed to promote positive health behaviors. Guided by TPB, an SDBT-RT program was developed, taking into account the rural community context-including local policies, lifestyle habits, and social networks-as well as individual-level characteristics. The formulation of a research protocol that incorporates the model's core constructs warrants further investigation. At the level of behavioral attitude, reminiscence therapy sessions are used to evoke positive memories, foster a constructive outlook on aging, and strengthen the belief that "participating in this program can enhance my well-being". At the subjective norm level, the group-based intervention delivered in community centers helps establish supportive social norms. Peer observation and interaction reduce perceived barriers to participation. For perceived behavioral control, the SDBT component employs a progressive difficulty structure and real-time movement guidance to lower the perceived difficulty of performing the exercises.

The program was reviewed and revised by five experts in sports rehabilitation, medical psychology, geriatrics, health management, and nursing. Additionally, a pilot study was conducted prior to the main study to assess the feasibility of the intervention. The static-dynamic balance training component was derived from balancing postural control movements, with a gradual increase in intensity by varying sensory inputs and external distractions, and consisted of three parts: (1) a 10-minute warm-up phase (including range-of-motion exercises for the wrists, hips, shoulders, knees, and ankles); (2) a 15-minute static balance training session (standing on both feet; standing in parallel and tandem; standing in tandem; standing on one foot); and (3) a 25-minutes of dynamic balance training (normal gait; narrow gait; overlapping gait; tandem gait). RT is based on Erikson's theory of psychosocial development, which states that recalling life experiences can help rural older adults resolve the psychological crisis of integration and despair in the final stages of life. Therefore, a structured procedure of reviewing the past, returning to the present, evaluating the past, and facing the present was set up and, combined with the temporal characteristics of older Chinese people's lives, recreational activities, and traditional cultural practices; reminiscence therapy involves six themes: "Our Time," "My Happy Times," "Achievements in my life," "Revisiting Traditional Festivals," "My Hobbies," and "Feeling the good old days," promoting their self-integrity and optimism to face reality with positive goal orientation. Table 1 provides the content of the SDBT-RT.

Each group of interveners consists of general practitioners, community health workers and medical postgraduate students who have undergone one month of specialized training. Thirty-two people in the intervention group were randomly divided into 8-person groups, and the appropriate time periods (8:00-10:00) were selected according to the activity habits of the elderly in the community. The intervention sites are fixed as community activity centers equipped with multimedia facilities and green rest areas. The intervention lasted for 12 weeks. In odd-numbered weeks, a dual intervention model of "40-minute RT + 50-minute SDBT" was adopted to establish behavioral intentions, and behavioral attitudes and subjective norms were strengthened through RT. Synchronous balance training enhances perceptual behavioral control through immediate improvement of physical functions. In even weeks, only 50 minutes of SDBT is conducted. A single training can reduce cognitive load and focus on the solidification of motor skills. To record engagement in reminiscence therapy, a standardized observation checklist and participant feedback forms were used after each session to assess participation and emotional responses. Facilitators were trained to recognize distress or fatigue, with activities adapted to individual conditions and emergency protocols in place for physical or psychological incidents.

The implementer is required to fill out the "Implementation Fidelity Checklist" immediately after each session, recording whether the RT theme is carried out as per the weekly plan, whether the SDBT training is upgraded in stages, and the duration of the core links. The project supervisor randomly selects 20% of the checklists every week for phone review. When deviations are found, the implementers are required to explain the reasons and formulate improvement measures at the weekly regular meeting. Meanwhile, the implementers also need to record the physical and mental states of the participants and use resources such as unified theme audio and video, handicraft materials, festival decorations and life goal lists. During the intervention period, the intervention coordinator recorded the attendance of each participant in each course and promptly followed up on those who were absent to arrange make-up classes as much as possible. A "Behavior Log Form" was designed to record changes such as supplement use, recreational activities, and disease conditions. It was reviewed monthly by general practitioners to ensure that the intervention effect was not interfered with by confounding factors. During the 4-week follow-up, participants in the intervention group received four brief weekly phone calls (5-10 minutes each) to check on home practice adherence, provide encouragement, and answer basic questions. No new intervention content was introduced.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

盲法说明

Data Analyst

入排标准

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

入选标准

  • •(1) Age ≥ 60 years; (2) Independent walking ability for ≥ 15 consecutive minutes (without assistive devices); (3) Long-term rural residency (≥ 1 year); (4) Provided informed consent and willingness to cooperate

排除标准

  • •(1) a diagnosis of severe pre-existing physical illnesses, defined as conditions that significantly impair physical functioning or require regular medical intervention (e.g., advanced heart disease, cancer, or other major organ diseases); (2) cognitive impairment (Short Portable Mental Status Questionnaire score ≥ 3); (3) taking psychotropic medication; (4) participating in psychosocial /sports interventions and (5) severe visual or hearing impairment, as determined by the medical records.

研究组 & 干预措施

Control group

No Intervention

The control group received standardized health education and general exercise guidance delivered by trained staff at community centers. Biweekly, 40-minute, 12-week group sessions cover six topics: Static Balance Training Principles, Dynamic Equilibrium Skill Development, Psychosocial Adaptation Techniques, Fall Risk Mitigation Strategies, Home Environment Optimization, and Lifestyle Behavior Internalization, focusing on knowledge transmission and fundamental movement instruction.

Intervention group

Experimental

The intervention lasted for 12 weeks. In odd-numbered weeks, a dual intervention model of "40-minute RT + 50-minute SDBT" was adopted to establish behavioral intentions, and behavioral attitudes and subjective norms were strengthened through RT.

干预措施: The Static-Dynamic Balance Training Combined with Reminiscence Therapy (Behavioral)

结局指标

主要结局

The Healthy Aging Instrument (HAI)

时间窗: One month

The Healthy Aging Instrument (HAI) was developed by Thiamwong et al. and consists of 35 entries in 9 dimensions: Staying Cognitively Active, Staying Physically Active, Having Social Participation, Having Social Relationships and Support, Practicing Self-Care and Self-Awareness, Accepting Aging, Being Self-Sufficient and Living Simply, Making Merit and Good Deeds, and Managing Stress. A 5-point Likert scale was used (1 = not at all consistent, 2 = slightly consistent, 3 = not sure, 4 = moistening, physical functioning, social participation, social relationships and support, self-care, acceptance consistent, 5 = completely consistent). Total scores ranged from 35 to 175, with higher scores reflecting better levels of healthy aging, including more active engagement, stronger self-care, and greater psychosocial well-being. The Cronbach's α in the Chinese version was 0.93, and the internal consistency was good

次要结局

未报告次要终点

研究者

发起方
Xinyu Yang
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Xinyu Yang

Master of Science

Huzhou University

研究点 (1)

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