718892

research-article2017
CRE0010.1177/0269215517718892Clinical RehabilitationMarconcin et al.

CLINICAL
Original Article REHABILITATION

Clinical Rehabilitation

A randomized controlled trial of 1­–10

© The Author(s) 2017
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DOI: 10.1177/0269215517718892
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exercise intervention for elderly journals.sagepub.com/home/cre

people with osteoarthritis of the

knee: the PLE2NO program

Priscila Marconcin1,2, Margarida Espanha1,2,

Júlia Teles1,2, Paulo Bento3, Pedro Campos1,2,
Rui André4 and Flávia Yázigi1,5

Abstract
Objective: To assess the effectiveness of a 12-week self-management and exercise intervention (the
PLE2NO program) in elderly individuals with knee osteoarthritis.
Design: Randomized controlled trial.
Setting: Four different community settings.
Subjects: Eighty individuals aged 60 years or older with clinical and radiographic knee osteoarthritis
enrolled in the study.
Intervention: A combined self-management and exercise intervention (treatment group) and an
educational intervention (control group).
Main measures: The primary outcomes were pain and other knee osteoarthritis symptoms (swelling,
crackling, limitation on movement, and stiffness), self-management behaviors (communication with
physician and cognitive symptom management), and functional lower limb strength. Secondary outcomes
were knee osteoarthritis–specific health-related quality of life, self-perceived health, aerobic capacity,
lower and upper limb flexibility, and handgrip strength.
Results: In all, 67 participants, mean age 69.1 ± 5.8 years, completed the study: 32 in the Educational
Group and 35 in the Self-Management and Exercise Group. A significant group effect favorable to the
Self-Management and Exercise Group was observed in the following variables: communication with the
physicians (P = .048), aerobic capacity (P = .035), and functional lower limb strength (P = .015). Although
no significant group effect was detected, clinical improvements in pain (31%) and knee osteoarthritis

1Faculdade de Motricidade Humana, Universidade de Lisboa, 5Laboratório de Fisiologia e Bioquímica do Exercício,

Cruz Quebrada, Portugal Interdisciplinary Centre for the Study of Human Performance
2Neuromechanics Research Group—Interdisciplinary (CIPER), Cruz Quebrada, Portugal
Centre for the Study of Human Performance (CIPER), Cruz
Corresponding author:
Quebrada, Portugal
3Federal University of Paraná, Curitiba, Brazil Priscila Marconcin, Faculdade de Motricidade Humana,
4Rheumatology Service, Hospital Beatriz Ângelo, Loures, Universidade de Lisboa, Estrada da Costa, P-1499-002 Cruz
Quebrada, Dafundo, Portugal.
Portugal
Email: [email protected]
2 Clinical Rehabilitation 00(0)

symptoms (29%) were observed in the experimental group. No improvements regarding cognitive
symptom management, self-perceived health, lower limb flexibility, and handgrip strength were found.
Conclusion: This study supports the importance of a combined self-management and exercise
intervention to improve functional lower limb strength and aerobic capacity in a Portuguese sample.
Additionally, pain and other symptoms have improved clinically.

Keywords
Self-management, exercise, knee osteoarthritis, elderly

Received: 21 September 2016; accepted: 13 June 2017

Introduction
Knee osteoarthritis is a common cause of disability patients about exercise and ways to overcome the
in old age.1 The Osteoarthritis Research Society difficulties imposed by the pathology.
International recommends non-surgical manage- The purpose of this randomized controlled trial
ment as the core treatment for knee osteoarthritis. (RCT) was to investigate whether a 12-week treat-
Additionally, the patients should be involved in ment program of combined self-management and
self-management and exercise programs indepen- exercise intervention resulted in greater improve-
dently of possible comorbidities or the number of ment of knee symptoms, self-management behav-
joints affected by osteoarthritis.2 iors, physical fitness outcomes, and health-related
The benefits of land-based exercise on knee quality of life than an education program in the
osteoarthritis management that are consistently elderly with knee osteoarthritis:
mentioned in the literature are physical function
improvement and pain relief.3,4 Self-management Hypothesis 1. Patients receiving the self-man-
programs are committed to empowering individ- agement and exercise program will have clinical
uals to cope with the disease and live better qual- improvements in knee pain and symptoms
ity lives with fewer restrictions due to their (swelling, crepitus, limitation of movement, and
illness.5 However, the benefits in people with stiffness) at the 12-week follow-up compared
osteoarthritis are not clear.6 The effects of com- with patients in the education group.
bined exercise and self-management interven- Hypothesis 2. Patients receiving the self-manage-
tions have shown reduced pain and improved ment and exercise program will have enhance-
functions in patients with osteoarthritis, although ments in self-management behaviors, such as the
many of the reviewed studies have methodologi- use of cognitive skills and communication with
cal flaws, such as low statistical power, limited their physician, at the 12-week follow-up com-
blinding and randomization procedures, and pro- pared with patients in the education group.
tracted treatment regimens.7 Therefore, trials to
Hypothesis 3. Patients receiving the self-manage-
assess the effectiveness of combined self-man-
ment and exercise program will experience pro-
agement and exercise interventions may be war-
gression in functional strength, aerobic capacity,
ranted, especially in the Portuguese context; to
and flexibility at the 12-week follow-up com-
the best of our knowledge, this study is the first in
pared with patients in the education group.
this context. Culturally, the Portuguese popula-
tion has low health literacy and adopts a passive Hypothesis 4. Patients receiving the self-man-
attitude toward treatment.8 Thus, the combination agement and exercise program will exhibit
of self-management and exercise could educate greater improvement in their health-related
Marconcin et al. 3

quality of life at the 12-week follow-up than supervision of a member of the research team who
patients in the education group. did not take part in the subsequent phases of the
trial. The study was performed in the Lisbon
region, Portugal, in four different locations (two
Methods
senior universities, one community center, and one
This study was a 12-week, single-blinded, RCT in church) in the community. All assessments, except
which the participants were allocated into two for the X-ray, were conducted at the Faculty of
groups: (1) the Self-Management and Exercise Human Kinetics.
Group (SMEG) and (2) the Educational Group The SMEG (the treatment group) performed a
(EG). The study was conducted as a clinical regis- 90-minute intervention twice a week for 12 weeks.
tered trial (US National Institutes of Health, The maximum number of participants in each class
NCT02562833) and was approved by the Ethical was 15. The program was conducted in rooms with
Committee of the Faculty of Human Kinetics of the limited space and with tables and chairs, which
University of Lisbon (N = 43/2014). A detailed allowed easy reproduction in the community. The
methodology of the PLE2NO program can be found first 30 minutes of each session constituted the self-
in the previously published study protocol.9 management component, and the following 60 min-
Recruitment was conducted in the community utes were allotted for the exercise component. The
using various marketing strategies. After staff tele- EG (the control group) received a book,12 telephone
phone screening, all the subjects were invited to an calls, and three education sessions.
awareness session and completed an eligibility Both groups (SMEG and EG) also received a
questionnaire. Subjects who met the eligibility cri- supplement of glucosamine (1500 mg) and chon-
teria were referred for bilateral knee radiographs droitin (1200 mg) sulfates, harpagophytum extract
(anterior–posterior, lateral, and skyline views). (100 mg), and hyaluronic acid (10 mg) with a rec-
The eligibility criteria included knee osteoar- ommendation for the use of two sachets per day.
thritis (clinical and radiological criteria according Chondroitin in combination with glucosamine
to the American College of Rheumatology),10 an improves pain in osteoarthritis patients in the short-
age ≥60 years, being functionally independent, and term13 and therefore can help the participants exer-
full Portuguese language proficiency. The exclu- cise, since pain is the principal barrier for exercising
sion criteria were as follows: being involved in in osteoarthritis samples.14
other intervention programs (exercise, education, All measures were collected at baseline and
or physical therapy), having other pathologies (e.g. after intervention. The outcome assessors were
cardiovascular, respiratory, musculoskeletal, or blinded to the participants’ allocations.
cancer), knee joint replacement, recent knee sur- The primary outcomes were self-reported pain
geries or knee injections of corticosteroid or hyalu- and Other Symptoms (swelling, crepitus, limitation
ronic acid within the past six months, exposure to of movement, and stiffness) assessed by pain and
chondroitin and/or glucosamine in the three months the Other Symptoms dimension of the Knee Injury
prior to randomization, and allergies to shellfish. and Osteoarthritis Outcome Score (KOOS),15 self-
The knee osteoarthritis classification severity was management behavior assessed by the cognitive
determined by a rheumatologist, and patients with symptom management (CSM) and the communica-
Kellgren–Lawrence grades 1–4 were included.11 tion with physician (CWP) scales,16 and functional
All participants gave written informed consent lower limb strength assessed by the five repetition
prior to randomization. The randomization sit-to-stand test (FRSTST).17 The secondary out-
sequence was conducted with a 1:1 allocation into comes were knee osteoarthritis–specific health-
the two groups. As the participants finished the related quality of life, activities of daily living, and
baseline assessment, they received an opaque sports/recreation functions assessed by the KOOS
marked envelope with information about the treat- questionnaire,15 self-perceived health assessed by
ment group. This process was performed under the EuroQol five-dimension five-level visual analog
4 Clinical Rehabilitation 00(0)

scale (EQ-5D-5L-VAS),18 aerobic capacity assessed Of the 80 participants who began the PLE2NO pro-
by the 6-minute walk test (6MWT),19 lower body gram, 67 completed the postintervention assess-
flexibility assessed by the chair sit-and-reach (CSR) ment (35 in the SMEG and 32 in the EG) and were
test, overall shoulder flexibility assessed by the included in the main data analysis. Of the 13 par-
back scratch test (BST),20,21 and handgrip measured ticipants who did not complete the postintervention
by a handheld dynamometer.22 assessment, five dropped out due to health condi-
The sample size was determined using the tions not related to knee osteoarthritis and eight for
GPower 3.1 program.23 We selected one covariate other personal reasons.
and two groups for the a priori analysis through The participants’ baseline characteristics are
analysis of covariance (ANCOVA) with 80% shown in Table 1. No significant differences were
power at a 5% significance level. The a priori anal- found in demographic characteristics and body
ysis24 showed that a sample size of 67 participants composition between the EG and the SMEG.
were sufficient to detect a large effect size on the The mean differences within groups and the
pain dimension between the intervention and con- results of the ANCOVA to compare variables
trol groups. Considering a possible drop-out rate of between groups are shown in Tables 2 and 3.
20%, our goal was to recruit 80 subjects and allo-
cate 40 subjects per group.
Self-reported outcomes
The chi-square test of homogeneity, Mann–
Whitney test, or independent samples t-test was For all KOOS dimensions, only Other Symptoms had
used to compare demographic variables between a marginally significant group effect after adjusting
the EG and the SMEG at baseline, such as age, sex, for the baseline values. No group effect was found for
educational level, retired status, unilateral or bilat- the other KOOS dimensions. However, a significant
eral osteoarthritis, body mass index (BMI), osteo- clinical improvement (larger than 10 points)15 was
arthritis-specific measures, and the health-related found for all KOOS dimensions in the SMEG.
physical fitness assessment. Regarding self-management behaviors (Table
Univariate analyses of covariance were con- 3), a significant group effect was found in the CWP
ducted to compare the effects of the intervention scale with a small effect size (.058) but not in the
between groups (EG versus SMEG) based on the CSM scale.
primary and secondary variables by adjusting each The average score on the EQ-5D-5L-VAS
variable to the baseline value. The mean differences improved from baseline in both groups (11% for
within groups were calculated as Mom 1 (baseline) SMEG, t(34) = −2.21, P = .034, and 6% for EG
minus Mom 2 (after intervention program). The t(31) = −2.10, P = .044), but no significant group
non-parametric ANCOVA was used for the ordinal effect was found.
variable analysis. The effect size was quantified
using partial eta squared (η2). The effect size was
Health-related physical fitness
classified as small (partial η2 < .06), medium
(.06 ≤ partial η2 < .14), and large (partial η2 ≥.14).25 A significant group effect was found on the 6MWT
All statistical analyses were performed with the (P = .035), FRSTST (P = .015), and right limb BST
SPSS v.22 software using a significance level of 5%. (P < .001; Table 2). No group effects were found in
the BST left limb and the CSR (both knees).
Additionally, a complementary analysis in which
Results pain was recorded before and after the 6MWT
As shown in the flowchart (Figure 1), 224 subjects revealed a significant improvement after the inter-
were screened for eligibility. Of this group, 80 met vention (t(34) = 2.19; P = .018) in pain perception
the inclusion criteria and were enrolled in the study, during the 6MWT (measured using the visual analog
and 144 were excluded (of these, 133 were ineligi- pain scale) in the SMEG. The same finding was not
ble, and 11 were eligible but refused to participate). observed in the EG (t(31) = .32; P = .373).
Marconcin et al. 5

Figure 1. PLE2NO flowchart of the study design.

A large effect size was found for the BST of the described in the study protocol.9 Additionally, sup-
right arm (.191), and a medium effect size was plementation worked as a motivational tool to pro-
found for the 6MWT (.068) and FRSTST (.090). mote adherence to and maintenance of the program
because the participants recognized the effort
involved in providing an expensive treatment.
Discussion The main findings of this study demonstrated
This study had high compliance in both groups, that the participants in the SMEG had significantly
with a 12.5% drop-out rate in the SMEG and a 20% better results after the intervention than the indi-
drop-out rate in the EG. This high compliance viduals in the EG in the CWP scale (a component
might be justified by several strengths previously of the self-management behavior variable) and
6 Clinical Rehabilitation 00(0)

Table 1.  Participants’ baseline results.

Outcomes EG (n = 32) SMEG (n = 35) Total sample Test statistic P-value

Demographics  
  Age (years) 67.8 (5.3) 70.3 (6.1) 69.1 (5.8) 1.78a .080
  Female gender (%) 59.4 80.0 70.1 3.39b .108
  Educational level (%) 0.74b .466
  Elementary school 28.1 25.6 26.8  
   High school grades 9–12 15.6 28.6 22.4  
   High school graduated 25.0 22.9 23.9  
   College or more 31.3 22.9 26.9  
  Retired (%) 90.6 91.4 91.0 0.01b 1.00
  Bilateral knee osteoarthritis (%) 93.8 94.3 94.0 0.00b 1.00
  Kellgren–Lawrence grade (%) 2.43b .486
   1 and 2 50.0 62.9 56.4  
   3 and 4 50.0 37.1 43.5  
Body composition  
 Weight 79.2 (15.3) 78.8 (15.0) 79.0 (15.0) −0.12a .898
 Height 1.62 (.08) 1.56 (.09) 1.59 (.09) −2.64a .010*
  BMI (kg/m2) 30.1 (5.3) 32.3 (5.0) 31.2 (5.2) 1.73a .088

EG: Educational Group; SMEG: Self-Management and Exercise Group; BMI: body mass index.
Values are presented in percentages except for age, weight, height, and BMI, which are presented as the mean and SD.
aIndependent samples t-test.
bChi-square test of homogeneity.

*P < .05.

health-related physical fitness measures (aerobic Finally, the Chronic Disease Self-Management
capacity and functional lower limb strength). Program was developed in the United States and thus
CWP was a big concern for the PLE2NO partici- might not be appropriate for the cultural background
pants, possibly because culturally they placed great of the Portuguese population. Another European
responsibility for the success of their treatment on study that utilized the same program also did not find
physicians and, at the same time, had difficulty talk- a significant group effect on the above-mentioned
ing to and explaining their concerns with them. variable.26
Because self-management programs must be based Regarding the health-related physical fitness
on patient-perceived problems, the PLE2NO sessions component, functional lower limb strength and aero-
emphasized learning strategies to improve their com- bic capacity showed improvements with a group
munication skills and maintain a working relation- effect. Older adults with knee osteoarthritis are
ship with their physician. known to have both compromised lower extremity
However, the CSM scale did not show a signifi- strength and aerobic capacity compared with persons
cant group effect. One possible explanation is that of the same age without knee osteoarthritis.27 Thus,
the scale score is the mean of six items, each of which interventions should address both these limitations.
represents a different cognitive strategy (e.g. playing Moreover, the Osteoarthritis Research Society
mental games). Therefore, a person who started to International recommends the sit-to-stand test and
use only one or two strategies might have presented the 6MWT as two of the physical performance
a low score. Furthermore, the PLE2NO sample had measures for knee and hip osteoarthritis.28
diverse education levels, which created difficulties in The improvement in functional lower limb
the development of the self-management program. strength might be explained by the use of a rigorous
 Marconcin et al.

Table 2.  Group effect analysis for quantitative variables.

EG (n = 32) SMEG (n = 35) ANCOVA

  Mom 1 Mom 2 Changes Mom 1 Mom 2 Changes Group effect

  Mean (SD) Mean (SD) Mean (SD) Mean (SD) Mean (SD) Mean (SD) F P
KOOS Pain 61.4 (20.4) 67.4 (18.2) −6.0 (16.2) 52.1 (18.9) 68.2 (17.4) −16.0 (17.8) 2.41 .125
KOOS Symptoms 66.4 (22.7) 71.6 (21.3) −5.2 (15.9) 55.3 (21.0) 72.1 (17.5) −16.8 (17.2) 3.94 .051
KOOS ADL 64.9 (19.7) 73.6 (18.5) −8.7 (13.6) 49.7 (18.5) 65.7 (18.8) −16.0 (16.7) 0.33 .569
KOOS Sports/rec 38.1 (27.5) 42.9 (29.6) −4.8 (21.0) 22.3 (17.5) 35.3 (28.3) −13.0 (26.8) 0.44 .511
KOOS QOL 46.9 (27.4) 55.0 (24.5) −8.2 (18.0) 35.2 (20.0) 48.9 (22.8) −13.7 (19.5) 0.17 .684
EQ-5D-5F VAS 75.5 (13.3) 80.0 (13.2) −4.5 (12.2) 71.1 (19.5) 79.0 (14.9) −7.9 (21.2) 0.01 .894
6MWT (m) 470.5 (86.0) 466.6 (91.7) 3.9 (59.6) 423.6 (68.2) 455.9 (68.1) −32.3 (42.9) 4.64 .035*
CSRMPK (cm) −7.1 (12.0) −5.6 (12.8) −1.5 (9.6) −13.6 (16.5) −6.6 (14.4) −7.0 (10.9) 2.17 .145
CSRLPK (cm) −6.6 (9.9) −6.5 (11.53) −0.1 (9.5) −11.8 (14.9) −7.6 (14.1) −4.2 (8.9) 1.62 .208
BSTright (cm) −13.4 (11.4) −14.2 (11.4) 0.8 (4.3) −14.3 (13.4) −11.5 (11.9) −2.9 (3.7) 15.09 <.001***
BSTleft (cm) −18.9 (11.8) −16.8 (12.3) −2.2 (4.2) −19.2 (12.3) −16.1 (11.4) −3.1 (6.1) 0.49 .484
Handgrip test (kg) 30.04 (8.9) 30.07 (8.1) −0.03 (2.3) 27.98 (8.6) 28.65 (9.5) −.67 (2.7) 0.88 .351
FRSTST (s) 11.6 (2.9) 12.6 (4.3) −0.9 (3.3) 12.4 (3.4) 11.0 (3.2) −1.4 (3.8) 6.29 .015*

EG: Educational Group; SMEG: Self-Management and Exercise Group; ANCOVA: analysis of covariance; KOOS: Knee Injury and Osteoarthritis Outcome Score; ADL: activ-
ity of daily living; Sports/rec: sports and recreation; QOL: quality of life; EQ-5D-5L VAS: EuroQol five-dimension five-level visual analog scale; 6MWT: 6-minute walk test;
CSR: chair sit-and-reach; MPK: most painful knee; LPK: less painful knee; BST: back scratch test; FRSTST: five repetition sit-to-stand test.
ANCOVA adjusted for values at baseline.
*P < .05; ***P < .001.
7
8 Clinical Rehabilitation 00(0)

Table 3.  Group effect analysis for ordinal variables (self-management behaviors).

EG (n = 32) SMEG (n = 35) ANCOVA

  Mom 1, Mom 2, Mom 1, Mom 2, F P

median (IQR) median (IQR) median (IQR) median (IQR)
CWP 2.3 (1.9) 2.0 (2.2) 2.3 (1.4) 2.3 (2.4) 4.06 .048*
CSM 1.4 (1.4) 1.5 (1.5) 1.6 (1.3) 2.0 (1.3) 3.25 .076

EG: Educational Group; SMEG: Self-Management and Exercise Group; ANCOVA: analysis of covariance; CWP: communication
with physician; CSM: cognitive symptom management; IQR: interquartile range.
ANCOVA non-parametric test adjusted for baseline values.
*P < .05.

methodology in the strength training planning (per- exercise (especially walking) during the days on
sonalized load progression), which was designed to which there are no classes.
allow for a 0.250-g load increase each session and The improvements found in the performance-
minimal load control. This better exercise intensity based test can reflect positively on daily living
control permitted avoiding or minimizing pain after activities and have a substantial impact on the qual-
exercise. This improvement is crucial because ity of life. Analyzing performance-based tests is
symptomatic knee osteoarthritis is related to muscle important when considering the functional ability
strength, especially quadricep weakness.29 Progress framework that highlights the relationship among
in functional lower limb strength may have led to physical impairment, performance functional limi-
symptom relief in the PLE2NO sample. A similar tations, and physical disability/dependence.35
pattern was found with an eight-week strengthening Concerning self-reported pain, an improvement
exercise,30 a 12-week Thai Chi intervention,31 and was expected between the group analyses, although
an eight-week strengthening exercise with elastic this improvement did not occur. Nevertheless, we
bands.32 must highlight that the difference found in the
The 6MWT reveals not only physical endur- KOOS pain subscale was considered clinically rel-
ance but also the capacity to walk long distances, evant15 and was larger than 10 points in the inter-
which is important for overall functional ability. vention group (−16), whereas the control group
The improvement found in the SMEG corre- (−6) did not achieve this clinical difference.
sponded to an increase of 7.6% after the interven- Moreover, the average KOOS pain score in the
tion (equivalent to 32.3  m), which was not SMEG improved by 31% (P < .001), whereas the
clinically significant33 but represented an improved score in the EG improved by 10% (P = .042) after
walking ability. This finding is similar to the find- the intervention. The lack of a group effect is in
ings of other studies involving elderly individuals contrast to other studies with integrated educa-
affected by knee osteoarthritis that also showed a tional and exercise programs.24,36,37
significant improvement in the 6MWT.27,34 The KOOS Other Symptoms dimension (swell-
Additionally, the treatment group showed sig- ing, crepitus, limitation of movement, and stiffness)
nificantly less pain after the 6MWT after interven- showed a marginally significant group effect
tion. These findings indicated that the participants (P = .051). The average score in the SMEG
could walk increased distances with less pain, improved by 30% compared with 8% in the EG
which is extremely important in knee osteoarthritis after the intervention, which was also considered
subjects who usually consider pain an important clinically relevant.15 This improvement in the Other
barrier to the practice of any activity. The improve- Symptoms dimension could represent better overall
ment in this test is related to the self-management physical functions.38
component of the PLE2NO, which encourages the This study has limitations. First, we could not
subjects to perform more physical activity and blind the participants regarding the group allocation.
Marconcin et al. 9

Therefore, some self-reported measures may reflect R.A. revised critically, and gave the final approval of the
the respondents’ biases. Second, the control group version to be submitted. J.T. analyzed data, revised criti-
(EG) received three educational sessions and the cally, and gave the final approval of the version to be
PLE2NO book in addition to the regular treatment12 submitted.
and was encouraged to practice exercise at home,
which possibly triggered improvements and made the Declaration of Conflicting Interests
group effect analysis more difficult. In future studies, The author(s) declared no potential conflicts of interest
the control group should be provided only regular with respect to the research, authorship, and/or publica-
treatment to aid in the search for group effects. tion of this article.
In conclusion, the findings suggest that the
PLE2NO self-management and exercise interven- Funding
tion had a significant group effect in favor of the The author(s) disclosed receipt of the following financial
intervention group in self-management behavior support for the research, authorship, and/or publication of
(CWP) and health-related physical fitness out- this article: Pierre Fabre Médicament offered the supple-
comes (functional lower limb strength and aerobic ment used in the study and funded the advertising materi-
capacity). A clinical improvement in pain and other als and the book that were provided to the control group.
Ciência Sem Fronteiras (CsF), a Brazilian Scholarship
knee osteoarthritis symptoms was observed in the
Program, provided financial support for the first author.
SMEG. Healthcare providers may confidently rec-
ommend a self-management and exercise program
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