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

NCT06164847 | Completed DMC

• 1 other identifier: HSOS/2023/1/1
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Osteoporosis; Osteopenia; Bone Loss

Keywords

exercise adherence; exercise program; osteoporosis; older adults

Outcome Measures

Primary Outcomes (1)

• Exercise adherence

  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.

  Baseline-3 months

Secondary Outcomes (2)

• Functional lower extremity strength

  Baseline-3 months

• Fear of falling

  Baseline-3 months

Other Outcomes (1)

• Other variables of interest

  Demographics: baseline, Therapeutic alliance: 3 months

Study Arms (2)

AERO Program

EXPERIMENTAL

Before their first physiotherapy appointment, patients will be asked to respond to four specific questions to guide the treatment (see link below). After this, they will receive usual physiotherapy care and a HEP for managing osteoporosis. The number of exercises given for the HEP should minimally be three to maximum six, performed at least three days per week for 12 weeks (time of the final assessment). After providing the HEP, patients in the intervention group are asked questions which explore their subjective abilities of the COM-B Model (capability, opportunity, or motivation) of undertaking the exercise program. Based on these answers and with the help of further discussions with the patient, the physiotherapist makes an assessment and decides which domains of the COM-B model might be useful to target. In the following 30 minutes PT-sessions, the therapist suggests one or more specific actions to enhance adherence. The participants must attend at least 4 out of 6 sessions.

Behavioral: AERO Program

Standard care

ACTIVE COMPARATOR

The control group will receive six PT sessions as "standard care". The first session is 60 minutes and the following sessions are 30 minutes. In regular clinical practice, "standard care" for people with osteoporosis includes measures such as home exercise programs, mobilizations, soft tissue techniques, or training with gym equipment. The HEP in the control group is based on the physical assessment of the physical therapist. The therapists in the control group do not have any restrictions for the exercises chosen. The participants must attend at least 4 out of 6 sessions of the control program.

Other: Standard Care

Interventions

AERO Program BEHAVIORAL

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).

AERO Program

Standard Care OTHER

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

Standard care

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hochschule Osnabruck: lead
• LMU Klinikum: collaborator

Study Sites (1)

LMU Klinikum Großhadern

Munich, Bavaria, 81377, Germany

Location

Related Publications (12)

• Cummings SR, Cosman F, Lewiecki EM, Schousboe JT, Bauer DC, Black DM, Brown TD, Cheung AM, Cody K, Cooper C, Diez-Perez A, Eastell R, Hadji P, Hosoi T, Jan De Beur S, Kagan R, Kiel DP, Reid IR, Solomon DH, Randall S. Goal-Directed Treatment for Osteoporosis: A Progress Report From the ASBMR-NOF Working Group on Goal-Directed Treatment for Osteoporosis. J Bone Miner Res. 2017 Jan;32(1):3-10. doi: 10.1002/jbmr.3039. Epub 2016 Dec 27.

  PMID: 27864889 BACKGROUND

• Benedetti MG, Furlini G, Zati A, Letizia Mauro G. The Effectiveness of Physical Exercise on Bone Density in Osteoporotic Patients. Biomed Res Int. 2018 Dec 23;2018:4840531. doi: 10.1155/2018/4840531. eCollection 2018.

  PMID: 30671455 BACKGROUND

• Jack K, McLean SM, Moffett JK, Gardiner E. Barriers to treatment adherence in physiotherapy outpatient clinics: a systematic review. Man Ther. 2010 Jun;15(3):220-8. doi: 10.1016/j.math.2009.12.004. Epub 2010 Feb 16.

  PMID: 20163979 BACKGROUND

• Lachman ME, Lipsitz L, Lubben J, Castaneda-Sceppa C, Jette AM. When Adults Don't Exercise: Behavioral Strategies to Increase Physical Activity in Sedentary Middle-Aged and Older Adults. Innov Aging. 2018 Jan;2(1):igy007. doi: 10.1093/geroni/igy007. Epub 2018 Apr 5.

  PMID: 30003146 BACKGROUND

• Michie S, van Stralen MM, West R. The behaviour change wheel: a new method for characterising and designing behaviour change interventions. Implement Sci. 2011 Apr 23;6:42. doi: 10.1186/1748-5908-6-42.

  PMID: 21513547 BACKGROUND

• Rodrigues IB, Armstrong JJ, Adachi JD, MacDermid JC. Facilitators and barriers to exercise adherence in patients with osteopenia and osteoporosis: a systematic review. Osteoporos Int. 2017 Mar;28(3):735-745. doi: 10.1007/s00198-016-3793-2. Epub 2016 Oct 6.

  PMID: 27714441 BACKGROUND

• Room J, Dawes H, Boulton M, Barker K. The AERO study: A feasibility randomised controlled trial of individually tailored exercise adherence strategies based on a brief behavioural assessment for older people with musculoskeletal conditions. Physiotherapy. 2023 Mar;118:88-96. doi: 10.1016/j.physio.2022.08.006. Epub 2022 Aug 30.

  PMID: 36266133 BACKGROUND

• Room J, Hannink E, Dawes H, Barker K. What interventions are used to improve exercise adherence in older people and what behavioural techniques are they based on? A systematic review. BMJ Open. 2017 Dec 14;7(12):e019221. doi: 10.1136/bmjopen-2017-019221.

  PMID: 29247111 BACKGROUND

• Pinelli E, Barone G, Marini S, Benvenuti F, Murphy MH, Julin M, Kemmler W, Von Stengel S, Di Paolo S, Dallolio L, Maietta Latessa P, Zinno R, Bragonzoni L. Effects of COVID-19 Lockdown on Adherence to Individual Home- or Gym-Based Exercise Training among Women with Postmenopausal Osteoporosis. Int J Environ Res Public Health. 2021 Mar 2;18(5):2441. doi: 10.3390/ijerph18052441.

  PMID: 33801389 BACKGROUND

• Wocken, K. M. (2013): Exercise Adherence in Older Adults. In: The international journal of behavioral nutrition and physical activity.

  BACKGROUND

• Strüder, H. K. (2016): Leichtathletik. Trainings- und Bewegungswissenschaft - Theorie und Praxis aller Disziplinen. Unter Mitarbeit von Jonath, U., & Scholz, K. Köln: Sportverlag Strauß.

  BACKGROUND

• Dachverband Osteologie: DVO-Leitlinie Osteoporose - Kitteltaschenversion

  BACKGROUND

Related Links

• Study about the Behaviour change wheel, Pre \& Post Physiotherapy Questions of the Intervention Arm, Interventions based on the AERO Program for the Intervention Arm

MeSH Terms

Conditions

Osteoporosis; Bone Diseases, Metabolic

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants will be unaware of the hypothesis of this study to decrease performance biases. The statistician will be blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two groups (HEP, PT+AERO and HEP, PT-standard care) will receive the protocol at the same time period.

Study Record Dates

• First Submitted: December 1, 2023
• First Posted: December 11, 2023
• Study Start: November 3, 2023
• Primary Completion: July 31, 2024
• Study Completion: August 31, 2024
• Last Updated: October 30, 2024

Record last verified: 2024-10

Locations

DE (1)