- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01076413
Comparison of Two Exercise Interventions to Improve Gait in Older Persons (PRIME)
Comparison of Two Exercise Interventions to Improve Gait in Older Persons: The PRIME (Program to Improve Mobility in The Elderly) Study
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
The purpose of this research study is to compare two different exercise treatments for walking problems in older adults. We want to determine if participation in the exercise programs for 3 months will improve walking abilities by improving balance and strength.
Adults aged 65 years or older, who are able to walk without the help of another person, are being asked to participate. If you are able to walk independently and you have medical clearance from your physician to participate in activities requiring low to moderate physical activity, you are invited to participate. We plan to enroll 40 older adults, all who have small problems with walking due to balance or strength, in this research study.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, États-Unis, 15260
- University of Pittsburgh
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- 65 years of age and older
- Ambulatory without an assistive device or the assistance of another person
- Usual 4 meter gait speed ≥1.0 m/s
- Completes a figure-of-eight walk in > 8.0 seconds
Exclusion Criteria:
Inability to participate in testing:
- persistent lower extremity pain that is present on most days of the week and crepitus, tenderness or enlargement of joints of the lower extremity (arthritis).84
- back pain that is present on most days of the weeks and interferes with walking and activities of daily living or back pain that increases with walking (lumbar stenosis)
- calf pain or cramping which worsens with walking and is relieved by rest (PAD)
- refusal to walk on a treadmill
Safety concerns:
- dyspnea at rest or during activities of daily living or use supplemental oxygen (CHF, COPD)
- any acute illness or medical condition that is not stable according to the approving physician
- resting systolic blood pressure ≥ 200 mm Hg or diastolic blood pressure ≥ 100 mm Hg or resting heart rate > 100 or < 40 beats per minute85
- diagnosed dementia or cognitive impairment defined as a MMSE score < 24
- hospitalized in the past 6 months for acute illness or surgery, other than minor surgical procedures
- severe visual impairment with visual acuity < 20/70 with best correction
- history of stroke
- fixed or fused lower extremity joints such as hip, knee or ankle
- lower extremity strength <4/5 on manual muscle testing
- lower extremity amputation
- progressive movement disorder such as MS, ALS or Parkinson's disease
Plan d'étude
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: skill-based exercise
2 times per week for 12 weeks.
warm-up, stretching, strengthening, and skill-based exercises.
Pre-gait and gait activities including stepping patterns and walking patterns and treadmill training at various walking speeds
|
2 times per week for 12 weeks Pre gait and gait activities
|
|
Comparateur actif: aerobic exercise training
warm-up, strengthening and aerobic conditioning (treadmill walking)
|
2 times per week for 12 weeks.
aerobic conditioning exercise consisting of treadmill walking
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Gait
Délai: 12 weeks
|
gait characteristics, smoothness of walking, 6 MWT, complex walking tests, GARS-M, SPPB, energy cost, SAFFE, GES, figure of 8
|
12 weeks
|
|
Physical function
Délai: 12 weeks
|
LLFDI function and disability scales
|
12 weeks
|
|
Physical Activity
Délai: 12 weeks
|
Actigraph accelerometer
|
12 weeks
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Disability and health care costs
Délai: 6 months post exercise
|
Late Life Function and disability index, fall history and health care cost questionnaire will be administered through a phone interview 6 months following completion of the exercise program
|
6 months post exercise
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Publications et liens utiles
Publications générales
- Brach JS, Lowry K, Perera S, Hornyak V, Wert D, Studenski SA, VanSwearingen JM. Improving motor control in walking: a randomized clinical trial in older adults with subclinical walking difficulty. Arch Phys Med Rehabil. 2015 Mar;96(3):388-94. doi: 10.1016/j.apmr.2014.10.018. Epub 2014 Nov 10.
- Brach JS, Van Swearingen JM, Perera S, Wert DM, Studenski S. Motor learning versus standard walking exercise in older adults with subclinical gait dysfunction: a randomized clinical trial. J Am Geriatr Soc. 2013 Nov;61(11):1879-86. doi: 10.1111/jgs.12506. Epub 2013 Oct 28.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- PRO09080228
- K23AG026766 (Subvention/contrat des NIH des États-Unis)
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