The Balance and Foot Health Program for Older Adults: A Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 20
- 主要终点
- The change in the Timed Up and Go test time, expressed in seconds
研究概览
简要总结
Every year in France, 2 million falls by people over 65 are responsible for 10,000 deaths, the leading cause of accidental death, and more than 130,000 hospitalizations. The primary objective of this study is to compare the effectiveness of adding 12 weekly foot health workshops to balance workshops on mobility among older adults living in nursing homes, compared to a program based exclusively on balance workshops.
详细描述
The purpose of this multicenter cluster-randomized controlled trial is to evaluate whether a structured Foot Health Program combined with balance training improves functional outcomes in nursing home residents compared with balance training alone.
Foot disorders are common among older adults living in nursing homes and may contribute to impaired balance, reduced mobility, loss of functional independence, and increased risk of falls. Interventions targeting foot health, sensory stimulation, foot mobility, and foot muscle strengthening may represent an innovative approach to complement conventional fall prevention strategies. This study aims to assess the added value of a multimodal foot-focused intervention when combined with a standardized balance training program.
Twenty nursing homes (EHPADs) will participate in the study. Nursing homes will be randomized at the facility level in a 1:1 ratio to either the intervention group or the control group. Ten facilities will be allocated to the intervention group and ten facilities to the control group. A total of 200 participants will be enrolled, with approximately 10 residents recruited in each nursing home.
Prior to enrollment, eligibility criteria will be assessed during a screening visit. Study information will be provided to participants and, when applicable, to their legal representative or trusted person. Written informed consent will be obtained before participation in any study procedures.
At baseline (T0), demographic and clinical characteristics will be collected. All participants will undergo a podiatric assessment performed by a podiatrist involved in the study. Routine foot care will be provided when required. Baseline outcome assessments will be completed within 15 days before the first intervention session.
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
- None
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
- •People aged 65 and older.
- •Residents of nursing homes.
- •Able to walk, with or without a walking aid (cane, walker, etc.)
- •Residents at risk of falling, defined by at least one of the following criteria: history of a fall within the last 12 months; unsteadiness while walking or balance issues; limited mobility.
- •Able to understand and follow simple instructions.
- •Able to participate in workshops.
- •Enrolled in a social security program or beneficiaries of an equivalent program.
- •Individuals (participants, guardians, or conservators, as applicable) who have been informed and have provided written consent for their participation in the study.
排除标准
- •- Regular use of minimalist shoes at the time of enrollment.
- •Medical condition or clinical situation contraindicating the use of minimalist shoes, as determined by the investigator.
- •Use of orthopedic shoes prescribed by a healthcare professional.
- •Unhealed foot wound or active foot infection.
- •Recent lower limb fracture (< 3 months) or recent lower limb trauma, likely to limit participation in the workshops or contraindicate foot mobilization, as assessed by the investigator.
- •Severe cognitive impairment preventing the understanding of simple instructions or participation in the workshops.
- •Any other clinical condition deemed incompatible with participation in the study by the investigator.
研究组 & 干预措施
Experimental Group
Participants in the intervention group will attend weekly workshops as part of the Foot Health program (12 sessions), led by a mobile nurse trained in massage. The mobile nurse will perform all massages and lead the foot health workshops for all participants in the intervention group. Her status as a healthcare professional ensures the safety of the intervention. In addition, she is trained in wellness massage techniques.
Participants will also take part in 12 workshops focused on balance, led by a professional in adapted physical activity. This workshop will include recommended strength training and balance exercises.
干预措施: Weekly foot health workshops (Other)
Experimental Group
Participants in the intervention group will attend weekly workshops as part of the Foot Health program (12 sessions), led by a mobile nurse trained in massage. The mobile nurse will perform all massages and lead the foot health workshops for all participants in the intervention group. Her status as a healthcare professional ensures the safety of the intervention. In addition, she is trained in wellness massage techniques.
Participants will also take part in 12 workshops focused on balance, led by a professional in adapted physical activity. This workshop will include recommended strength training and balance exercises.
干预措施: Balance Workshops (Other)
Control group
The control group will participate only in 24 balance workshops. Balance workshops have been developed over the past decade to improve the independence of nursing home residents. However, their implementation varies widely from one facility to another, with differences in content, frequency, and instructors. This variability underscores the need to establish a common framework to ensure the comparability of interventions in a research setting.
干预措施: Balance Workshops (Other)
结局指标
主要结局
The change in the Timed Up and Go test time, expressed in seconds
时间窗: at baseline assessment (T0) and after the 12 intervention sessions (T1)
The Timed Up and Go is a commonly used screening tool to assess mobility in older adults. The participant must stand up from a chair, walk a distance of three meters, turn around, then walk back to the chair and sit down. These tasks must be performed in a comfortable and safe pace. A practice trial is allowed to help the individual become familiar with the task. The individual wears their usual shoes. The use of a walking aid is permitted, but its use must be noted on the data collection form. No physical assistance is provided. The TUG is also sensitive to changes, detecting improvements or deteriorations in functional mobility. It has high validity, being able to correctly identify fallers and non-fallers with a sensitivity and specificity of 87%. Finally, this test is accurate, simple to administer, and useful for assessing functional mobility, particularly in older or medically compromised populations.
次要结局
- Changes in the position of the center of pressure during static stance(at baseline assessment (T0) and after the 12 intervention sessions (T1) and 6 months (T2).)
- Changes in the muscle strength of the flexors of the big toes (hallux)(at baseline assessment (T0) and after the 12 intervention sessions (T1) and 6 months (T2).)
- Changes in ankle joint range of motion during dorsiflexion and plantar flexion(at baseline assessment (T0) and after the 12 intervention sessions (T1) and 6 months (T2).)
- Changes in participants' fear of falling(at baseline assessment (T0) and after the 12 intervention sessions (T1) and 6 months (T2).)
- Changes in foot pain experienced while walking(at baseline assessment (T0) and after the 12 intervention sessions (T1) and 6 months (T2).)
- The Evolution of Mobility Through the TUG(after the 12 intervention sessions (T1) and 6 months (T2).)
- The incidence of falls measured over the course of the study(From baseline assessment (T0) until 6 months (T2))
- Participants' satisfaction with minimalist shoes and the various workshops(after the 12 intervention sessions (T1) and 6 months (T2).)
- The number of hours per day that shoes were worn by participants in the experimental group(after the 12 intervention sessions (T1) and 6 months (T2).)