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HIGH AND LOW INTENSITY PROGRESSIVE RESISTED EXERCISES ON PAIN, RANGE OF MOTION AND FUNCTIONAL DISABILITY

30 décembre 2021 mis à jour par: Saiqa Kanwal, University of Lahore

COMPARATIVE EFFECTS OF HIGH AND LOW INTENSITY PROGRESSIVE RESISTED EXERCISES ON PAIN, RANGE OF MOTION AND FUNCTIONAL DISABILITY IN KNEE OSTEOARTHRITIS PATIENTS WITH SARCOPENIA: A RANDOMIZED CONTROLLED TRIAL

The study will be randomized controlled trial. This study will be conducted in University of Lahore Teaching Hospital, Lahore, Pakistan. A sample size of 84 will be randomly allocated into two experimental groups, (42 participants in each group), by computer generated random number list. The participants,randomly allocated to the experimental group A, will receive high intensity resisted exercises ,in addition with routine physical therapy as TENS (transcutaneous electrical nerve stimulator), Hot pack, Deep friction massage Each session will be of 35-45 minutes with 5 minutes warm up, 35 minutes for training session and lastly 5 minutes for cool down

• Participants in experimental group B, will receive Low intensity resisted exercises in addition with routine physical therapy

Aperçu de l'étude

Description détaillée

Recruitment: Participants will be recruited and referred by orthopedic doctor, University of Lahore Teaching Hospital to Physical Therapy Department. The study will be randomized controlled trial. This study will be conducted in University of Lahore Teaching Hospital, Lahore, Pakistan. A sample size of 84 will be randomly allocated into two experimental groups, (42 participants in each group), by computer generated random number list. The participants,randomly allocated to the experimental group A, will receive high intensity resisted exercises ,in addition with routine physical therapy as TENS, Hot pack, Deep friction massage

  • Participants in experimental group B, Low intensity resisted exercises in addition with routine physical therapy
  • Both experimental groups will receive sixteen treatment sessions and those will be given over a period of eight weeks (2 sessions per week, each session of 35-45 minutes with 5 minutes warm up and lastly 5 minutes for cool down in both groups.
  • Outcome measure will be taken by assessor at baseline, and at the end of 8th week (at the end of last treatment session) through Numeric pain rating scale and KOOS
  • Randomization and Allocation: Afterwards, participants confirming the eligibility criteria will be randomly allocated, through computer generated random number list , into two experimental groups (Group A, Group B).
  • Blindness: Study will be single, assessor blinded and an independent investigator will perform randomization and will inform the patients and therapist about the allocation.
  • Intervention: Leg presses, knee extension, hip adduction and hip abduction exercises will be performed by patients. There will be a warm up sets for 1 repetition maximum with 2 min gap between both sets (leg press + knee extension exercises) (hip abduction and hip adduction) patients will ask to perform.
  • Duration: Sixteen treatment sessions will be given over a period of eight weeks (2 sessions per week, each session of 35-45 minutes).
  • Outcome Variables and Measures

    1. Pain (Numeric pain rating scale)
    2. Functional disability (KOOS)
    3. ROM (Universal Goniometer)
  • Outcome measures will be taken at baseline and at the end of last treatment session i.e. 8th week. Collected data will be than analyzed.

Type d'étude

Interventionnel

Inscription (Anticipé)

84

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Muhammad Haider Ullah Khan, MS PTN
  • Numéro de téléphone: 03314127210
  • E-mail: haiderullah@live.com

Sauvegarde des contacts de l'étude

Lieux d'étude

    • Punjab
      • Lahore, Punjab, Pakistan, 55150
        • Recrutement
        • University of Lahore Teaching Hospital
        • Chercheur principal:
          • Saiqa Kanwal, MS-MSK*
        • Sous-enquêteur:
          • Syed Asadullah Arslan, Phd
        • Sous-enquêteur:
          • Bilal umar, BSPT, DPT,Phd

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

35 ans à 65 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Both genders.
  • Age range between 35-65 years
  • Diagnosed osteoarthritis patients of grade I to III according to kellgren & Lawrence on X-ray (diagnosed by orthopedic specialist)
  • Diagnosed patients with sarcopenia according to SARC-F questionnaire. (diagnosed by orthopedic specialist)

Exclusion Criteria:

  • Patients with history of trauma like RTA(road traffic accident)

    , fall history and other loading injuries, patellar fracture or dislocation.

  • Patients with history of surgery (meniscal reconstruction, TKR(total knee replacement) or Partial Knee Replacement etc.)
  • Patients with severe patellofemoral osteoarthritis.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: High intensity

Intervention: Leg presses, knee extension, hip adduction and hip abduction exercises will be performed by patients. There will be a warm up sets for 1 repetition maximum with 2 min gap between both sets (leg press + knee extension exercises) (hip abduction and hip adduction) patients will ask to perform.Routine physical therapy including TENS, Hot pack and Deep friction massage along with high intensity exercises will also be delivered along with Muscle Energy Technique. Experimental:High intensity will be treated with high intensity exercises in such a way that

1st and 2nd week; resistance training will be of 50% 1RM with 4 sets of 10 repetitions.

3rd and 4th week: resistance training will be of 70% 1RM with 4 sets of 10 repetitions.

5th and 6th week: the training will be of 80% 1RM with 4 sets of 10 repetitions

Last 4 sessions will be:

7th and 8th week: resistance training will be of 80% 1RM with 5 sets of 10 repetitions.

Intervention:Leg presses, knee extension, hip adduction and hip abduction exercises will be performed by patients. There will be a warm up sets for 1 repetition maximum with 2 min gap between both sets (leg press + knee extension exercises) (hip abduction and hip adduction) patients will ask to perform.

Both groups will receive routine physical therapy (Tens, Hot pack, Deep friction massage) in addition with experimental interventions

Expérimental: Low intensity

Intervention: Leg presses, knee extension, hip adduction and hip abduction exercises will be performed by patients. There will be a warm up sets for 1 repetition maximum with 2 min gap between both sets (leg press + knee extension exercises) (hip abduction and hip adduction) patients will ask to perform.Routine physical therapy including TENS, Hot pack and Deep friction massage along with Low intensity exercises will also be delivered along with Muscle Energy Technique. Experimental:Low intensity Group B will be treated with low intensity exercise in such a way that,

1st and 2nd week; Resistance training will be of 20% 1RM with 4 sets of 15 reps 3rd and 4th week Resistance training will be of 30% 1RM with 4 sets of 15 reps 5th and 6th week: the training will be of 40% 1RM with 4 sets of 15 reps

Last session will be:

7th and 8th week; Training of 40% 1RM with 5 sets of 15 reps

Intervention:Leg presses, knee extension, hip adduction and hip abduction exercises will be performed by patients. There will be a warm up sets for 1 repetition maximum with 2 min gap between both sets (leg press + knee extension exercises) (hip abduction and hip adduction) patients will ask to perform.

Both groups will receive routine physical therapy (Tens, Hot pack, Deep friction massage) in addition with experimental interventions

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Numeric Pain Rating Scale (NPRS)
Délai: 8 weeks
The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain
8 weeks
Knee injury and Osteoarthritis Outcome Score (KOOS)
Délai: 8 weeks
The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a knee-specific instrument, developed to assess the patients' opinion about their knee and associated problems. The KOOS evaluates both short-term and long-term consequences of knee injury. It holds 42 items in 5 separately scored subscales; Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL)
8 weeks
Range of motion
Délai: 8 weeks
Range of motion is the extent of movement of a joint, measured in degrees of a circle. Universal goniometer (UG) will be used to evaluate range of motion (ROM)
8 weeks

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chercheur principal: Saiqa Kanwal, MS-MSK*, University of Lahore

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

10 novembre 2021

Achèvement primaire (Anticipé)

8 juillet 2022

Achèvement de l'étude (Anticipé)

18 juillet 2022

Dates d'inscription aux études

Première soumission

30 décembre 2021

Première soumission répondant aux critères de contrôle qualité

30 décembre 2021

Première publication (Réel)

13 janvier 2022

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

13 janvier 2022

Dernière mise à jour soumise répondant aux critères de contrôle qualité

30 décembre 2021

Dernière vérification

1 décembre 2021

Plus d'information

Termes liés à cette étude

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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