Effect of a resistance and balance exercise programme for women with osteoporosis and vertebral fracture: study protocol for a randomized controlled trial

Brita Stanghelle, Hege Bentzen, Lora Giangregorio, Are Hugo Pripp, Astrid Bergland, Brita Stanghelle, Hege Bentzen, Lora Giangregorio, Are Hugo Pripp, Astrid Bergland

Abstract

Background: Osteoporotic vertebral fractures are common, and are associated with reduced functioning and health related quality of life. The primary aims of this randomized controlled trial are to examine the immediate and long-term effects of a 12-weeks supervised group exercise programme on habitual walking speed in older women with osteoporosis and a history of vertebral fracture. The secondary aims are to examine the immediate and long-term effects of the exercise program on physical fitness, fear of falling and quality of life.

Methods: The study is a single-blinded randomized controlled trial. Women aged 65 years or older with osteoporosis and a history of vertebral fracture are included. The intervention group receives a 12-week multicomponent exercise programme, including resistance training combined with balance training. The control group receives usual care. Adherence to the programme will be of importance for the internal validity of the study. Participants in the exercise group who don't attend will be followed up with motivational phone calls. The primary outcome is habitual walking speed over 10 m. Secondary outcomes are health related quality of life (Qualeffo-41, SF-36), physical activity (I-PAQ), Patient Specific Functional Scale, Fear of falling (FES-1) and physical fitness (Senior Fitness test, Functional reach test, 4 square step test, grip strength). Sample size, based on the primary outcome, is 150 participants randomized into the two arms on a 1:1 allocation, including an estimated 20% drop out. Descriptive data will be reported as mean (standard deviation), median (range) or count (percent) as appropriate. The data will be analysed following the intention-to-treat principle. Between group differences in primary and secondary outcomes at 3 months follow-up will be assessed using linear regression models with respective outcome at baseline as covariate and the randomised group as factor.

Discussion: This trial will generate new knowledge on the effects of a multicomponent exercise programme among women over 65 years with osteoporosis and a history of vertebral fracture, knowledge that is of importance for clinicians, health managers and policy makers.

Trial registration: ClincialTrials.gov Identifier: NCT02781974 . Registered 18.05.16. Retrospectively registered.

Keywords: Exercise; Health related quality of life; Osteoporosis; Physical function; Vertebral fracture.

Conflict of interest statement

Ethics approval and consent to participate

The project proposal has been approved by Regional Committee for Ethics in Medical Research (South-East Norway) with the registration number 2014/2050.

A written informed consent will be obtained from all participants included in the analyses, and the project is conducted according to the World Medical Association Declaration of Helsinki.

Consent for publication

Not applicable

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Flow of participants in the study

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