NCT04108650

Portuguese Fit & Strong! for Older Adults With Osteoarthritis

Completed NA Last updated 11 January 2021

What this trial tests

NA trial testing Fit & Strong! group in Osteoarthritis in 31 participants. Completed in 24 March 2020.

Timeline

18 September 2017

Primary endpoint
27 February 2019

24 March 2020

Quick facts

Lead sponsor	Universidade do Porto
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	other
Enrollment	31
Start date	18 September 2017
Primary completion	27 February 2019
Estimated completion	24 March 2020
Sites	1 location across Portugal

Drugs / interventions tested

• Fit & Strong! group

Conditions studied

• Osteoarthritis — all drugs for Osteoarthritis →

Sponsor

Universidade do Porto — full company profile →

Who can join

50 and older, any sex, with Osteoarthritis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Exercise for osteoarthritis of the knee.
   Lawford BJ, Hall M, Hinman RS, Van der Esch M, et al · · 2024 · cited 37× · PMID 39625083 · DOI 10.1002/14651858.cd004376.pub4