Primary Objective:• To determine the impact of different types and intensities of physical activities, i.e. running, cycling, tennis and hiking, on the structural progression of knee OA in a group of early-stage knee OA patients.Secondary Objectives…
ID
Source
Brief title
Condition
- Musculoskeletal and connective tissue disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Differences in structural progression of knee OA between the selected physical
activities (running, cycling, tennis, and hiking) after 24 months follow-up,
scored using our recently introduced definitions for longitudinal evaluation of
OA MRI features.
Structural progression of knee OA: scored using recently proposed definitions
by our research group for longitudinal evaluation of OA MRI features.
All subregional change scores (1 for progression, *1 for improvement and 0 for
no change) will be summed over the different MRI Osteoarthritis Knee Score
(MOAKS) subregions into an overall measure of change per feature.
The summed change scores per feature will consequently be dichotomized into
progression versus no progression (change score >= 1 = progression, change score
< 1 = no progression).
Secondary outcome
1. Differences in clinical progression of knee OA expressed as change on
sub-scales of KOOS and patient nominated activity pain score between the
selected physical activities (running, cycling, tennis, and hiking) after 24
months follow-up.
2. Association between GPS-based individual activity profiles and increased
risk of knee OA progression
3. Interaction between inflammation (including inflammatory markers IL-6, CRP,
proteomics and questionnaire data) and genetics and physical activity on the
progression of clinical and structural knee OA
4. Interaction between physical activity and known risk factors for knee OA, on
the progression of knee OA
5. Role of the microbiome on the progression of knee OA in different types
of physical activities.
6. Interaction between daily activities and the progression of knee OA in
different types of physical activities.
Background summary
Knee osteoarthritis (OA) is a chronic condition that is characterised by pain
and impaired function and contributes hugely to physical disability on
population level. With the growing elderly population worldwide, the prevalence
of OA will increase and is estimated to be the number one chronic disease in
the Netherlands in 2040.
There is an ongoing debate regarding the amount of exercise that is healthy for
the joint, since specific types of loading can threaten the integrity of joint
tissues and therefore develop or accelerate OA.
Some studies have tried to elucidate the association between sports activity
and the progression of knee OA.
Unfortunately, there is no clear outcome so far and, to our knowledge, no
prospective studies have been performed .
There is therefore urgent need to further investigate the impact of physical
activity on the progression of knee OA.
Study objective
Primary Objective:
• To determine the impact of different types and intensities of physical
activities, i.e. running, cycling, tennis and hiking, on the structural
progression of knee OA in a group of early-stage knee OA patients.
Secondary Objectives:
• To examine the impact of different types and intensities of physical
activities (running, cycling, tennis, and hiking) on the clinical progression
of knee OA in early-stage knee OA patients after 24 months.
• To examine associations between inflammation and physical activity on the
progression of knee OA after 24 months.
• To investigate the role of genetics in the progression of knee OA in
different types of physical activities (running, cycling, tennis, and hiking).
• To investigate the interaction between physical activity and known risk
factors for knee OA, on the progression of knee OA.
• To investigate the role of the microbiome on the progression of knee OA
in different types of physical activities.
• To investigate the interaction between daily activities and the
progression of knee OA in different types of physical activities.
Study design
The study design is a prospective cohort study of 332 patients with early signs
of knee OA who perform different types of physical activity (running, cycling,
tennis or hiking).
Patients will be followed for a period of 24 months. The setting where the
study will be designed and the data collected and handled is the Erasmus MC
University Medical Center.
At baseline patients will fill out an online questionnaire, an MRI-scan of the
knee will be made, a stoolsample collected, blood serum (e.g. IL-6, CRP,
genetics) will be extracted, and a physical examination will be performed.
Hikers, runners and cyclists are requested to track their physical activity
with a wearable GPS-device. This includes smartphone applications (e.g. Strava,
Runkeeper, Wahoo, Garmin, sensor logger) or sports watches used during their
physical activity. Data extracted will include time spent on physical activity
session, distance and speed per activity.
All tennis players are asked monthly about the average number of hours played
per type of game (singles vs doubles, free play vs training vs matches) and the
most played surface (clay, smashcourt, grass/artificial grass, hardcourt, or
indoor (carpet)) per week in the past month.
Patients will be asked to wear an activity monitor twice, for one week during
the first and last half year of participation.
During follow-up, patients will receive a monthly questionnaire to collect
information on the progression of the knee OA and a question for the hikers,
runners and cyclists to share their GPS training data from the wearable
devices.
At 24 months follow-up patients will receive another MRI-scan of the knee, a
physical examination, and blood serum (e.g. IL-6, CRP) will be extracted.
Study burden and risks
The study population will not be exposed to any risks. The burden of
participation consists of completing a total of 25 online questionnaires
(baseline approximately 20-30 minutes, monthly questionnaire approximately 5-10
minutes, 3-monthly questionnaire approximately 10-20 minutes), two
examinations including a physical examination, blood samples, MRI-scan of the
knee and a sinlge stoolsample collection. Each examination will take
approximately 1 hour.
Additionally, they are all asked to track their physical activities using GPS
wearable devices and register daily activities twice for one week using an
activity monitor (Actigraph) based on accelerometry.
Doctor Molewaterplein 40
Rotterdam 3015 GD
NL
Doctor Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
Patients (m/f) aged 45-65 years
Presence of non-traumatic knee complaints for at least three months
NICE guideline diagnosis of clinical knee OA (i.e. aged 45 or over and activity
related joint pain and either no morning joint-related stiffness or morning
stiffness that lasts no longer than 30 minutes)
Average physical activity level of the performed type of activity, which is
their primary sport activity, in the last 6 months:
o Running: >= 60 minutes running per week
o Cycling: >= 120 minutes cycling per week
o Tennis: >= 1 hour (match and/or training session) per week
o Hiking: >= 1 hike of at least 10km per week
Exclusion criteria
Other pathological conditions that could explain knee complaints like traumatic
onset knee complaints, presence of other forms of arthritis (rheumatoid
arthritis, psoriatic arthritis), pre-patellar bursitis or patellar tendinitis
Onset of knee complaints > 24 months ago
Contraindications for MRI
No mobile phone or wearable device to track physical activity and unwilling to
share tracked physical activity data.
Presence of any complaints other than knee OA resulting in physical impairment
that will limit the physical activity
Unwilling to participate
No or insufficient knowledge of Dutch language
No access to e-mail
Surgery on the affected knee in the last six months
Planned surgery on the affected knee in the period of participation
Fulfilling the inclusion criteria for more than one of the four physical
activities.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL81561.078.22 |