Effectiveness of the Adherence for Exercise Rehabilitation in Older People (AERO) Program to Improve Adherence in People with Osteoporosis in a German Context: a Randomized Parallel, Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Exercise adherence
研究概览
简要总结
The goal of this pilot study is to investigate the effect of an evidence-based adherence promoting intervention on exercise adherence of patients with osteoporosis. For this reason, a randomized controlled pilot trial with an intervention period of three months will be conducted.
Question I:
To which extent does an adherence-promoting intervention (AERO) have an effect on adherence to long-term exercise programs in patients with osteoporosis compared to conventional standard care with home-based exercise therapy?
Objective II:
Does the AERO Intervention influence fall risk factors such as functional lower extremity strength and fear of falling compared to conventional standard care plus home-based exercise therapy in patients with osteoporosis? Patients will be randomized to two groups: an intervention and a control group. Both groups will receive instructions for a home exercise program (HEP) during six physical therapy (PT) sessions.
The intervention group will receive a HEP and additionally the so-called AERO (Adherence for Exercise Rehabilitation in Older people) intervention within 6 PT-Sessions. The AERO program is a feasible intervention for boosting the exercise adherence of older people. The AERO intervention is an evidence-based adherence promoting intervention approach to help patients adhere to an exercise program.
The control group will receive six PT sessions as "standard care". In regular clinical practice in Germany "standard care" for people with osteoporosis include measures such as home exercise programs, mobilisations, soft tissue techniques, or training with gym equipment. This will be delivered based on each PT clinical reasoning with no additional motivation for adherence to the exercise program.
详细描述
"Osteoporosis is a disease which causes the bones to become porous, weak and fragile. The result: a higher risk of broken bones, known as fragility fractures. Pain, fear of falling as well as reduced physical and social activity are also known complications that immensely impact the quality of life of patients with osteoporosis.
A common treatment goal in osteoporosis is the reduction of falls and fractures. Next to medication and dietary changes physical activity plays an important role in managing osteoporosis. The effectiveness of physical activity in people with osteoporosis has already been established. Strengthening exercises targeting the lower extremities have shown the largest effect for the bone mineral density (BMD) measured at the neck of the femur. These results are also enclosed in the German Osteoporosis Guideline: enhancing strength, coordination, and balance by promoting regular physical activity as part of the prevention and basic treatment plan for osteoporosis.
To achieve these goals, exercise needs to be executed thoroughly for a prolonged period of time and therefore treatment adherence to these exercise programs is crucial. Adherence itself is defined by the World Health Organization (WHO) as: ".... 'the extent to which a person's behavior corresponds with agreed recommendations from a healthcare provider." People with osteoporosis often have problems to adhere with any exercise program prescribed. About 50% of the participants of exercise programs quit these programs after six months. Rodrigues et al., analyzed 54 studies using exercises and reported adherence rates between 51% and 100%.
Multiple reasons, which are being referred to as barriers (e.g., lack of time, family priorities, monetary issues) are proposed as being linked to non-adherence. Therefore, measures that promote adherence towards these regimens are needed to ensure the long-term effects and benefits of exercise programs. It is crucial that patients conform to the recommendations made by the health care providers. The best exercise program is unsuccessful if it is not being followed.
Based on the literature and a previous review conducted by our team, only a few studies were found that looked at ways for improving adherence in individuals with osteoporosis. However, none of these studies investigated adherence as a primary outcome but only as a secondary outcome in regard to a specific exercise program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participants will be unaware of the hypothesis of this study to decrease performance biases. The statistician will be blinded to group allocation.
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of osteoporosis by a physician.
- •able to speak and understand German.
- •women or men Age ≥ 50 years old.
- •able to make one repetition of the 30s sit-to-stand test.
- •Ability to perform Physical Therapy (PT) sessions and perform exercises (time/schedule/monetary).
- •Be referred to physiotherapy by a physician.
排除标准
- •cognitive impairment/ unable to follow instructions of the physiotherapist.
- •secondary bone loss due to other disorders or medication in the last 5 years (e.g., cancer).
- •conditions that would make participation in this study unsafe or would confound the results (e.g., renal failure, heart failure, cardiac diseases, pacemaker).
- •current participation in other physio-individual therapy or part stationary, multimodal therapy programs at the same time.
- •acute fractures (fracture within the last 6 weeks).
- •Mini Cognitive Score of ≤ 3
结局指标
主要结局
Exercise adherence
时间窗: Baseline-3 months
Exercise adherence will be measured via Outcome Expectations for Exercise Scale-2 and (OEE-2 scale) and via self-reported exercise diaries. The chosen outcome expectations for exercise scale 2 is a 13-item self report questionnaire to assess negative and positive exercise outcome expectations in older adults and is validated to the German language. Nine items rank positive expectations, and four items rank negative expectations. Each item can be rated from 1 (strongly disagree) to 5 (strongly agree). Low mean scores in the positive expectations part of the OEE-2 indicate positive expectations of exercise, high mean scores indicate negative expectations of exercise. High mean scores in the negative expectations part of the OEE-2 indicate positive expectations, low mean scores in the negative expectations part of the OEE-2 indicate low expectations of exercise. This measurement was included to investigate if the AERO intervention changes the expectations of the patient about exercise.
次要结局
- Functional lower extremity strength(Baseline-3 months)
- Fear of falling(Baseline-3 months)