Portuguese Fit & Strong! for Older Adults With Osteoarthritis
NCT04108650 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 31
Last updated 2021-01-11
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.
Conditions
Interventions
- OTHER
-
Fit & Strong! group
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.
Sponsors & Collaborators
-
Instituto de Ciências Biomédicas Abel Salazar (ICBAS)
collaborator UNKNOWN -
Centro de Investigação em Tecnologias e Serviços de Saúde
collaborator OTHER -
Fundação para a Ciência e a Tecnologia
collaborator OTHER -
Universidade do Porto
lead OTHER
Principal Investigators
-
Natália Duarte, Master · ICBAS, CINTESIS, University of Porto
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-09-18
- Primary Completion
- 2019-02-27
- Completion
- 2020-03-24
Countries
- Portugal
Study Locations
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