NCT07085884

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 11, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2023

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

July 17, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 25, 2025

Completed
Last Updated

July 25, 2025

Status Verified

July 1, 2025

Enrollment Period

5 months

First QC Date

July 17, 2025

Last Update Submit

July 17, 2025

Conditions

Keywords

Reminiscence therapybalance training

Outcome Measures

Primary Outcomes (1)

  • The Healthy Aging Instrument (HAI)

    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

    One month

Study Arms (2)

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.

Behavioral: The Static-Dynamic Balance Training Combined with Reminiscence Therapy

Interventions

The intervention group received a 12-week SDBT-RT program, conducted twice weekly: 40-minute reminiscence therapy plus 50-minute balance training in odd weeks, and 50-minute balance training alone in even week.

Intervention group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • (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

You may not qualify if:

  • (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Huzhou university

Huzhou, Zhejiang, 313000, China

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Data Analyst
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: The Theory of Planned Behavior (TPB), an extension of the Theory of Reasoned Action, evaluates individuals' intentions to engage in specific behaviors by considering both personal and social determinants of intention . TPB comprises four key constructs: attitude, subjective norm, perceived behavioral control, and behavioral intention. Previous studies have demonstrated that TPB has strong predictive validity for health behaviors requiring self-regulation, such as physical activity, making it a suitable framework for designing health interventions .
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Master of Science

Study Record Dates

First Submitted

July 17, 2025

First Posted

July 25, 2025

Study Start

May 11, 2023

Primary Completion

September 28, 2023

Study Completion

September 28, 2023

Last Updated

July 25, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations