Portuguese Fit & Strong! for Older Adults With Osteoarthritis

NCT04108650 | Completed

• 1 other identifier: F&S/111533/2015
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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

Osteoarthritis

Keywords

Physical Activity; Health Education; Fit & Strong!

Outcome Measures

Primary Outcomes (14)

• Change in Physical Performance measured at baseline and posttest

  The Short Physical Performance Battery was used to assess the physical performance. The Short Physical Performance Battery comprises a set of objective measures of lower extremity physical performance, including walking speed, chair-stands test, and balance test. Each physical performance measure was categorized into scale from 0 to 4, with 0 representing inability to do the test and 4 representing the highest level of performance. The scores of the three measures were summed with a score ranging from 0 to 12 and a higher score indicating better performance.

  2 months

• Change in Physical Performance measured at baseline and 4-months follow-up

  The Short Physical Performance Battery was used to assess the physical performance. The Short Physical Performance Battery comprises a set of objective measures of lower extremity physical performance, including walking speed, chair-stands test, and balance test. Each physical performance measure was categorized into scale from 0 to 4, with 0 representing inability to do the test and 4 representing the highest level of performance. The scores of the three measures were summed with a score ranging from 0 to 12 and a higher score indicating better performance.

  4 months

• Change in pain measured at baseline and posttest

  Pain was assessed by the Knee Injury and Osteoarthritis Outcome Score for people with knee OA; and by Hip disability and Osteoarthritis Outcome for people with hip OA. A score for each dimension is calculated as the sum of the items that are included, which is then converted to a 0-100 scale in which 0 represents extreme problems and 100 represents no problems.

  2 months

• Change in pain measured at baseline and 4-months follow-up

  Pain was assessed by the Knee Injury and Osteoarthritis Outcome Score for people with knee OA; and by Hip disability and Osteoarthritis Outcome for people with hip OA. A score for each dimension is calculated as the sum of the items that are included, which is then converted to a 0-100 scale in which 0 represents extreme problems and 100 represents no problems.

  4 months

• Change in stiffness measured at baseline and posttest

  Stiffness was assessed by the Knee Injury and Osteoarthritis Outcome Score for people with knee OA; and by Hip disability and Osteoarthritis Outcome for people with hip OA. A score for each dimension is calculated as the sum of the items that are included, which is then converted to a 0-100 scale in which 0 represents extreme problems and 100 represents no problems.

  2 months

• Change in stiffness measured at baseline and 4-months follow-up

  Stiffness was assessed by the Knee Injury and Osteoarthritis Outcome Score for people with knee OA; and by Hip disability and Osteoarthritis Outcome for people with hip OA. A score for each dimension is calculated as the sum of the items that are included, which is then converted to a 0-100 scale in which 0 represents extreme problems and 100 represents no problems.

  4 months

• Change in functionality measured at baseline and posttest

  Functionality was assessed by the Knee Injury and Osteoarthritis Outcome Score for people with knee OA; and by Hip disability and Osteoarthritis Outcome for people with hip OA. A score for each dimension is calculated as the sum of the items that are included, which is then converted to a 0-100 scale in which 0 represents extreme problems and 100 represents no problems.

  2 months

• Change in functionality measured at baseline and 4-months follow-up

  Functionality was assessed by the Knee Injury and Osteoarthritis Outcome Score for people with knee OA; and by Hip disability and Osteoarthritis Outcome for people with hip OA. A score for each dimension is calculated as the sum of the items that are included, which is then converted to a 0-100 scale in which 0 represents extreme problems and 100 represents no problems.

  4 months

• Change in moderate and vigorous physical activity measured at baseline and posttest

  Physical activity was assessed by International Physical Activity Questionnaire. This instrument provides information on time spent walking, in vigorous and moderate intensity activity and in sedentary activity. The scale consists of six questions: the number of days on which vigorous physical activity was performed in the previous seven days and the usual duration of such activity; the number of days on which moderate physical activity was performed in the previous seven days and the usual duration of such activity; and the number of days on which the person walked for at least 10 minutes in the previous seven days and the usual duration of walking.

  2 months

• Change in moderate and vigorous physical activity measured at baseline and 4-month follow-up

  Physical activity was assessed by International Physical Activity Questionnaire. This instrument provides information on time spent walking, in vigorous and moderate intensity activity and in sedentary activity. The scale consists of six questions: the number of days on which vigorous physical activity was performed in the previous seven days and the usual duration of such activity; the number of days on which moderate physical activity was performed in the previous seven days and the usual duration of such activity; and the number of days on which the person walked for at least 10 minutes in the previous seven days and the usual duration of walking.

  4 months

• Change in depression and anxiety symptoms measured baseline and posttest

  Depression and anxiety were assessed by the Hospital Anxiety and Depression Scale. It includes 14 items, seven of which assess anxiety and seven of which assess depression. Each item is scored on a four-point scale (from 0 to 3), with possible scores for each subscale (anxiety and depression) ranging from 0 to 21 points. A score of 11 or higher indicates the probable presence of the mood disorder.

  2 months

• Change in depression and anxiety symptoms measured baseline and 4-months follow-up

  Depression and anxiety were assessed by the Hospital Anxiety and Depression Scale. It includes 14 items, seven of which assess anxiety and seven of which assess depression. Each item is scored on a four-point scale (from 0 to 3), with possible scores for each subscale (anxiety and depression) ranging from 0 to 21 points. A score of 11 or higher indicates the probable presence of the mood disorder.

  4 months

• Change in fear of movement measured at baseline and posttest

  Fear of movement was assessed by the Brief Fear of Movement Scale. This instrument consists of 6 items scored on a 4-point scale from "strongly agree" to "strongly disagree". Higher scores indicate higher fear of movement.

  2 months

• Change in fear of movement measured at baseline and 4-months follow-up

  Fear of movement was assessed by the Brief Fear of Movement Scale. This instrument consists of 6 items scored on a 4-point scale from "strongly agree" to "strongly disagree". Higher scores indicate higher fear of movement.

  4 months

Other Outcomes (4)

• Age

  Baseline (Day 0)

• Sex

  Baseline (Day 0)

• Marital Status

  Baseline (Day 0)

Study Arms (2)

Fit & Strong! group

EXPERIMENTAL

The experimental group (23 participants) was enrolled in the intervention, the Fit \& Strong! program. The program consists in 24 sessions each divided in two parts. The first part is the exercise component (60 minutes) and the second is the educational component (30 minutes). The program was provided in two classes, the first class took place from October to December 2017 and the second class took place from October to November 2018. The experimental group was enrolled in the intervention (8 weeks).

Other: Fit & Strong! group

Control group

NO INTERVENTION

To participants in the control group (8 participants) were offered the possibility of enrolling in the program the following year after posttest measurement for both the intervention and control groups was complete.

Interventions

Fit & Strong! group OTHER

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.

Fit & Strong! group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 50 years or older,
• lower extremity OA diagnosed according to the clinical criteria of the American College of Rheumatology (ACR) \[14,15\], and
• doctor's authorization to participate.

You may not qualify if:

• no recent (\<6 months) joint replacements,
• no steroid injections in the last 3 months,
• no moderate to severe cognitive impairment,
• no rheumatoid arthritis,
• no diabetes mellitus and/or uncontrolled hypertension,
• no other health condition for which multicomponent physical exercise is not recommended.

Sponsors & Collaborators

• Universidade do Porto: lead
• Instituto de Ciências Biomédicas Abel Salazar (ICBAS): collaborator
• Centro de Investigação em Tecnologias e Serviços de Saúde: collaborator
• Fundação para a Ciência e a Tecnologia: collaborator

Study Sites (1)

Instituto de Ciências Biomédicas Abel Salazar, Universidade do Porto

Porto, 4050-313, Portugal

Location

Related Publications (4)

• Duarte N, Hughes SL, Paul C. Cultural adaptation and specifics of the Fit & Strong! program in Portugal. Transl Behav Med. 2019 Jan 1;9(1):67-75. doi: 10.1093/tbm/iby003.

  PMID: 29546428 BACKGROUND

• Hughes SL, Seymour RB, Campbell R, Pollak N, Huber G, Sharma L. Impact of the fit and strong intervention on older adults with osteoarthritis. Gerontologist. 2004 Apr;44(2):217-28. doi: 10.1093/geront/44.2.217.

  PMID: 15075418 BACKGROUND

• Hughes SL, Seymour RB, Campbell RT, Desai P, Huber G, Chang HJ. Fit and Strong!: bolstering maintenance of physical activity among older adults with lower-extremity osteoarthritis. Am J Health Behav. 2010 Nov-Dec;34(6):750-63. doi: 10.5993/ajhb.34.6.10.

  PMID: 20604699 BACKGROUND

• Hughes SL, Seymour RB, Campbell RT, Huber G, Pollak N, Sharma L, Desai P. Long-term impact of Fit and Strong! on older adults with osteoarthritis. Gerontologist. 2006 Dec;46(6):801-14. doi: 10.1093/geront/46.6.801.

  PMID: 17169935 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis; Motor Activity; Health Education

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Behavior; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior

Study Officials

• Natália Duarte, Master

  ICBAS, CINTESIS, University of Porto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Experimental and control group had no interaction to each other during the study. For data collection was used an individual interview in a place that guarantee privacy. None participant were aware about the group that they will be allocated before the baseline assessment.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2019
• First Posted: September 30, 2019
• Study Start: September 18, 2017
• Primary Completion: February 27, 2019
• Study Completion: March 24, 2020
• Last Updated: January 11, 2021

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)