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Effectiveness of the Adherence for Exercise Rehabilitation in Older People (AERO) Program in People with Osteoporosis

NCT06164847 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2024-10-30

No results posted yet for this study

Summary

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.

Conditions

Interventions

BEHAVIORAL

AERO Program

HEP, identification of barriers for exercise using the COM-B model. Interventions for these barriers: Review of HEP, review of method of delivery, cues, reminders, discussion of barriers and problem solving, motivational interviewing, decision balance sheets, behavioural contract, goal setting reviews, monitoring calls (detailed description in the link below).

OTHER

Standard Care

home exercise programs, mobilisations, soft tissue techniques, or training with gym equipment

Sponsors & Collaborators

  • LMU Klinikum

    collaborator OTHER

  • Hochschule Osnabruck

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-03
Primary Completion
2024-07-31
Completion
2024-08-31

Countries

  • Germany

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06164847 on ClinicalTrials.gov