NCT06164847Completed
Effectiveness of the Adherence for Exercise Rehabilitation in Older People (AERO) Program in People with Osteoporosis
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
Source: ClinicalTrials.gov · Last updated 30 Oct 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 24 (actual)
- First submitted
- 1 Dec 2023
- Start date
- 3 Nov 2023
- Primary completion date
- 31 Jul 2024
- Lead sponsor
- Hochschule Osnabruck
- Diseases
- Osteoporosis
- NCT number
- NCT06164847
What you commit to
- Study type: Interventional
- Participants enrolled: 24
- From 3 Nov 2023 to the primary completion date, 31 Jul 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- current participation in other physio-individual therapy or part stationary, multimodal therapy programs at the same time.
Other illness
- 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).
Other
- acute fractures (fracture within the last 6 weeks).
- Mini Cognitive Score of ≤ 3
Who the study is looking for
- 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.
Age in the registry: 50 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| LMU Klinikum Großhadern Coordinator of this site? Confirm its status | Munich | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.