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Résztvevőt keres itt: DániaFázis nélkül

Feasibility of an Early Home-based Cycling Intervention After Knee Arthroplasty

A legfontosabb adatok

Ki végzi
Central Jutland Regional Hospital
Hol
Silkeborg (Dánia)A helyszín megnézése
Azonosító
Állapot
Toboroz
Résztvevők
24 fő, tervezett
Kezdés
2026. szept. 21.
Várható befejezés
2028. márc.
A vizsgálat típusa
Beavatkozással járó, 2 csoportAz egyik csoport egy már használt kezelést kap, összehasonlításként.
A vizsgált kezelések
  • Early home-based stationary cycling
  • Usual care: home-based exercise programme
A regiszteradat frissítve
2026. október 2.

Ki vehet részt

MI-összefoglaló

A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.

The trial is looking for adults who are scheduled for knee replacement surgery on one knee. It tests whether adding home cycling on an exercise bike to the usual home exercises works in practice.

Életkor
18 years and older
Nem
All sexes
A betegség stádiuma
Scheduled for a first (primary) knee replacement on one knee: either a partial replacement of the inner side of the knee (medial UKA) or a total knee replacement (TKA).
Korábbi kezelés
People cannot join if they had an osteotomy (bone-cutting surgery) around the knee. They also cannot join if a tibial condyle fracture in that knee was fixed with plates or screws. They cannot join if they had leg surgery within 3 months before the knee replacement.

A részvétel fő kizáró okai

  • Leg surgery within 3 months before the knee replacement, or planned within 3 months after it
  • Inflammatory joint disease
  • Health problems that make cycling unsafe, such as unstable heart, lung or chronic nerve-degenerating disease, or cancer treatment that would get in the way
  • Knee bends too little before surgery to turn a full pedal circle
  • Current or recent alcohol or drug misuse, or memory problems or mental illness that would stop the person from following the cycling plan

A regiszter feltételei, szó szerint

Mind a 13 feltétel megnézéseKevesebb

Ki vehet részt

  • Scheduled for unilateral primary medial unicompartmental knee arthroplasty (UKA) or total knee arthroplasty (TKA)
  • Age ≥ 18 years
  • Able to speak and read Danish
  • Daily access to a stationary bike during the intervention period, or willingness to use a stationary bike provided by the study through an external rental company for the duration of the intervention. Due to logistical constraints, loan bikes can only be provided to participants residing within approximately one hour of transport from Aarhus or Silkeborg. Participants living outside this area may participate if they have access to a stationary bike
  • Ability to use a smartphone with internet connectivity (required for completion of electronic questionnaires and using SENS motion application) or a tablet and having an email address enabling completion of electronic questionnaires

Ki nem vehet részt

  • Previous surgery in either lower limb within 3 months before the date of knee arthroplasty or planned surgery in either lower limb within 3 months after the date of knee arthroplasty
  • Previous osteotomy around the knee or tibial condyle fracture that has been treated with osteosynthesis in the affected knee
  • Inflammatory joint disease
  • Medical or physical conditions that would prevent safe participation in the cycling intervention (e.g., unstable cardiovascular, pulmonary, or chronic neurodegenerative disorders)
  • Active cancer treatment, if this treatment would interfere with safe participation or adherence to the cycling protocol
  • Current or recent history of alcohol and/or substance misuse, as identified during the anaesthetic pre-assessment and documented in the electronic patient record
  • Cognitive impairment (e.g. dementia) or diagnosed psychiatric disorder that would prevent the patient from understanding or adhering to the cycling protocol
  • Preoperative reduced knee flexion preventing full pedal rotation on a stationary bike

Helyszínek itt: Dánia

  • Regional Hospital SilkeborgSilkeborg, DániaContact: Mette Garval, MScRésztvevőt keres

A vizsgálatról

Mit akar kideríteni a vizsgálat

The goal of this pilot clinical trial is to evaluate whether an early, home-based stationary cycling programme, provided in addition to standard postoperative home exercises, is feasible and acceptable for patients recovering from knee arthroplasty. It will also inform the design of a larger clinical trial examining the effects of adding early cycling to standard postoperative home exercises on postoperative outcomes.

A teljes eredeti leírásKevesebb

The main questions it aims to answer are:

* Can the cycling programme and planned study procedures be delivered as intended? * Are participants willing and able to take part in the study and follow the planned interventions? * Do participants find the cycling programme and outcome assessments acceptable? * What changes, if any, are needed before conducting a larger clinical trial?

Researchers will compare an early home-based stationary cycling programme provided in addition to standard postoperative home exercises with standard postoperative home exercises alone.

Participants will:

* Be randomly assigned to either the cycling group or the standard exercise group (control group) two weeks after surgery. * If assigned to the cycling group, perform 30 minutes of stationary cycling at home at least five days per week for eight weeks in addition to the standard postoperative home exercise programme. * If assigned to the control group, follow the standard postoperative home exercise programme and refrain from structured cycling during the eight-week intervention period. * Complete questionnaires and physical assessments at baseline and follow-up visits. * Complete selected patient-reported outcome measures at 6 and 12 months after surgery.

A vizsgálat 2 csoportja

  • Early home-based stationary cyclingA vizsgált kezelés

    Participants will begin a home-based stationary cycling programme two weeks after knee arthroplasty. They will perform 30 minutes of stationary cycling at least five days per week for eight weeks, in addition to the standard postoperative home-based exercise programme.

  • Usual care: home-based exercise programmeMár használt kezelés, összehasonlításként

    Participants will follow the standard postoperative home-based exercise programme beginning two weeks after knee arthroplasty. The programme focuses on knee mobility and muscle activation and does not include the stationary cycling intervention.

Kérdések a vizsgálat csapatának

  1. Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
  2. Megtérítik az utazási költséget?
  3. Megtarthatom a saját orvosomat?
  4. Mi történik, ha ki akarok lépni?

Contact the study team: see the registry record → Contacts and Locations

Oldal nyomtatása az orvosomnak

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on.
Hivatalos cím
Feasibility of Adding Early Home-based Cycling to Standard Exercises After Knee Arthroplasty: A Pilot Randomised Controlled Trial
MI-összefoglaló
A vizsgálat saját részvételi feltételeiből. Gépi kiolvasás: 2026. november 14.
A regiszteradat frissítve
2026. október 2.