Effects of Intensive Aerobic and Muscle Endurance Exercise in Patients With Systemic Sclerosis - a Pilot Study
Exercise
Maladies du tissu conjonctif+4
+ Signes et symptômes
+ Maladies de la peau
Étude thérapeutique
Résumé
Date de début de l'étude : 1 octobre 2009
Date à laquelle le premier participant a commencé l'étude.The purpose of the study is to examine the effect of an eight week intensive aerobic exercise and muscle endurance training program for patients with systemic sclerosis and 50-100 % of forced vital capacity. As systemic sclerosis is a very rare condition a Single Subject Experimental Design (SSED) was used including a 6-week non-interventional A-phase where patients are assessed systematically followed by an 8-week interventional B-phase where patients exercise three days a week with continued systematic assessments. According to the 2-standard deviation (2 SD) band analysis, statistical analysis were performed for each patient individually. Accordingly, a statistically significant change was detected if two consecutive assessments in the B-phase exceeded the 2 standard deviations (SD) of the mean of the A-phase. Patients were recruited from an ongoing study at the Karolinska University Hospital with the purpose to screen all patients with systemic sclerosis in Stockholm for cardiovascular disease. All patients meeting the inclusion criteria were invited to participate in this exercise study. Assessments: The six minute walking test was used to assess physical capacity. A submaximal treadmill test was used to estimate oxygen uptake in ml/kg x min. Muscle endurance was assessed by the Functional Index 2 registering the number of correct performed repetitions in 7 muscle groups. Pain, Raynaud's Phenomenon, fatigue and global disease impact on general well-being was assessed by the Visual Analogue scale (VAS), 0-100. Limitations in activities of daily living were assessed using the Health Assessment Questionnaire and the SF-36 was included to assess perceived health. The Exercise program: The program starts with a 10-minute warm-up session with biking at an intensity corresponding to perceived light exertion (10 on the Borg RPE, 6-20 scale). Thereafter, the load is increased to reach an intensity corresponding to perceived heavy exertion (15 on the Borg RPE scale) for an additional 15 minutes. During the last five minutes of the biking session, the loads are reduced to an intensity corresponding to light exertion. Heart rate was is recorded with a pulse watch (RS100 Polar) and peripheral saturation recorded with a heart rate oximeter (Wristox 3100 Nonin Medical). During the first weeks patients start on lower leads and increasing to the goal intensity. After the biking exercises, the participants perform repetitive dynamic muscle resistance training with the goal to achieve as many repetitions as possible in shoulder flexion and in hip flexion.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.4 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.De 18 à 80 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.Un seul groupe d'intervention est désigné dans cette étude
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Groupe I
ExpérimentalObjectifs de l'étude
Objectifs principaux
Objectifs secondaires
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site
Karolinska Univeristy Hospital, Solna
Stockholm, SwedenOuvrir Karolinska Univeristy Hospital, Solna dans Google Maps