CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 31 enrolled
Drug / intervention
Fit & Strong! groupother
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04108650
NCT04108650N/ACompleted

Portuguese Version of the Fit & Strong! Program for Older Adults With Osteoarthritis

Universidade do Porto·interventional·Posted Sep 30, 2019·Updated Jan 11, 2021

In Brief

A clinical study evaluating Fit & Strong! group for Osteoarthritis. Completed, enrolled 31 participants across 1 site.

Detailed Summary

Fit \& Strong! (F\&S!) is a non-pharmacological intervention designed for older people with osteoarthritis with proven efficacy. This program was developed and implemented among American patients. It is composed by two components: physical exercise with health education. In total, the program last eight weeks, and meets three times per week (24 sessions), for 90 minutes per session. The nationals and internationals statistics showed that Portugal has a high prevalence of OA, in particular in the knee or hip. Considering this fact and the negative impact in OA patients' lives the F\&S! program was culturally adapted for Portugal, which constitutes its first formal adaptation to an international population and setting. Therefore, a randomized controlled trial was developed to the effects of F\&S! among Portuguese older adults with lower-extremity OA, particularly, with respect to physical performance (walking speed, balance, lower body strength), pain, stiffness, functionality, physical activity, anxiety, depression and fear of movement. Participants were identified and referred from the electronic medical record maintained by general practitioners in Health Care Centers. Participants were randomly allocated to the experimental or to the control and were assessed three times (baseline, posttest and 4-months follow-up). Data analysis included descriptive statistics (medians and interquartile ranges) to describe participants' characteristics. The comparison between the experimental and the control group at baseline was performed using the Mann-Whitney U test for continuous variables and the Fisher test for categorical variables. Within each group, changes over time (pretest, posttest, follow-up) were analyzed using the Wilcoxon signed-rank test. Between group comparisons of differences in outcome variables between pretest, posttest and 4-month follow-up were analyzed using the Mann-Whitney U test.

Study Details

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedSep 30, 2019
Enrollment StartSep 18, 2017
Primary CompletionFeb 27, 2019
Study CompletionMar 24, 2020
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 6.8 years ago

Interventions

Fit & Strong! groupother

Consistent with the original format of F\&S!, the classes met three times per week for 90 minutes each for 8 weeks (24 sessions in total). Each class session consisted of 60 minutes of exercise and 30 minutes of health education. The exercise protocol included 10 minutes of warm-up and cool-down exercises, 20 minutes of low-intensity aerobic exercises, and 20 minutes of lower extremity strengthening exercises. The health education program focused on symptom management and behavioral strategies to increase physical activity and commitment to lifestyle change.