Proposal of an Adapted Physical Activity Exercise Protocol for Women with Osteoporosis-Related Vertebral Fractures: A Pilot Study to Evaluate Feasibility, Safety, and Effectiveness

Abstract

A quasi-experimental pilot study was performed to determine the feasibility and safety of an Adapted Physical Activity (APA) protocol and its effect on health-related quality of life (HRQOL), fear of falling, pain, and physical performance in women with osteoporosis-related vertebral fractures. Forty-four post-menopausal women (mean age: 67.6 ± 4.6) with osteoporotic vertebral fractures were assigned to an exercise group (APA group = 26) who attended a six-month exercise protocol that included postural and muscular reinforcement exercises, and a control group (CG = 18) who was asked to maintain their current lifestyle. At baseline and six months after baseline, HRQOL was measured as primary outcome by the Assessment of Health Related Quality of Life in Osteoporosis (ECOS-16) questionnaire. Secondary outcomes were fear of falling (Fall Efficacy Scale International, FES-I), lumbar back pain (Visual Analogue Scale-VAS), functional exercise capacity (Six Minutes Walking Test-6MWT, Borg scale), balance and gait (Tinetti Scale), and flexibility of the column (Chair Sit-and-Reach). The effects of the intervention were analyzed by comparison within groups and between groups. Effect sizes (ES) were calculated using Cohen’s d. All the outcomes significantly improved in the APA group, while they remained unchanged in the CG. After adjustment for unbalanced variables, the comparison between groups showed significant effects of the intervention for ECOS-16-score, functional exercise capacity, balance, and gait. The exercise program had big effect sizes on HRQOL (ES = 1.204), fear of falling (ES = 1.007), balance (ES = 0.871), and functional exercise capacity (ES = 1.390). Good adherence (75.8%) and no injuries were observed. Due to its feasibility, safety, and effectiveness, the proposed exercise protocol can be adopted in APA programs addressed to patients with osteoporosis-related vertebral fractures.

The Effect of Physical Activity on Bone Biomarkers in People With Osteoporosis: A Systematic Review

“…In spite of this, aerobic exercises have great benefits on the cardiovascular and metabolic apparatus and body composition of osteoporotic patients. In addition, exercise can help to achieve beneficial and significant effects on quality of life, balance, and functional mobility also in patients with osteoporosis-related vertebral fractures (43,44). However, there is still no agreement on which type of exercise, in terms of intensity, frequency, duration, type and setting, is optimal and can affect bone metabolism in people with osteoporosis (45)(46)(47).…”

“…Biomarkers of bone metabolism, reflecting the cellular activity linked to the bone turnover process, could be a valid tool to assess the efficacy of PA and exercise programs in the osteoporotic population. Of note, some studies, which we excluded after our preliminary full-test analysis because they include non-osteoporotic study groups, monitored the benefits of physical activity on bone metabolism by the evaluation of P1NP and CTX, the two biomarkers considered specific for bone turnover (44,48). Interestingly, an improvement in bone metabolism was induced by different types of exercise, for example a football training intervention (49,50).…”

Factors Affecting Persistent Postoperative Pain in Patients with Hip Fractures

“…The Fall Efficacy Scale (FES) questionnaire was used to express the degree of concern about the possibility of falling during the execution of 10 ADL. The FES uses a four-level Likert Scale, and each level corresponds to a score ranging from 1 (not at all worried) to 4 (very worried) [ 20 ]. The individual scores are added together to calculate a total score ranging from 10 to 40.…”

A Randomized Clinical Trial to Evaluate the Efficacy and Safety of the ACTLIFE Exercise Program for Women with Post-menopausal Osteoporosis: Study Protocol

“…Considering an alpha error of 0.05 and a power of at least 0.8, the minimum size of the sample was estimated in 18 patients per group, for a total of 36 patients. Considering a 15% drop-out (estimated on the basis of the experience of a previous study focused on patients with OP vertebral fractures [16]), preferring to be even more conservative, we estimated an appropriate sample size of 26 patients for each group, for a total number of 52 participants. Power analysis was carried out with G*Power 3.1.9.2.…”

“…This paper aimed at presenting the protocol of a randomized trial for evaluating the efficacy of a physical activity program (12-month duration) designed to improve the quality of life in women with post-menopausal OP when administered IHT or GGT. We relied on the most recent scientific evidence in this field, to develop the exercise program designed to improve the quality of life in this population [15][16][17]. We hypothesize that efficacy and safety of the exercise program are equal when administered as GGT or IHT.…”