Portuguese Fit & Strong! for Older Adults With Osteoarthritis

NCT04108650 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2021-01-11

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04108650 on ClinicalTrials.gov