Home Based Exercise Program for Elderly Cancer Patients
Single Institution Randomized Controlled Study of a Home Based Exercise Program to Reduce Functional Decline, Cancer Related Fatigue (CRF and Improve Quality of Life for the Elderly Gynecologic Oncology Patient)
Implementation of a home based exercise program to reduce functional decline, cancer related fatigue (CRF) and improve quality of life in the elderly gynecologic oncology patient
Problem:
Can prevention of CRF and loss of function improve QOL in the elderly gynecologic oncology patient undergoing chemotherapy?
Support:
Fatigue and its impact on QOL is a major concern with the elderly patient receiving chemotherapy. When compared to younger adults QOL is more important than gain in survival for elderly patients. (Eyigor, et al., 2010).
The National Comprehensive Cancer Network recommends exercise as the most effective intervention for cancer related fatigue.
Methods:
This is a single institution randomized controlled study to evaluate a home based exercise program in elderly gynecologic oncology patients undergoing chemotherapy. Subjects will be randomized to the intervention group or to the control group receiving usual care.
Intervention group will receive a home exercise program 3 days weekly consisting of 30mins of strength and aerobic activity, utilizing a follow along exercise DVD and patient log to assist with compliance.
The two groups will be compared by 1) objective PT assessment with the Berg Balance and 6 minute walk test (before or after) Cycle 1 and 6, 2) subjective nursing assessment with the NHANES (National Health and Nutrition Examination Survey) and FACIT- F (Functional Assessment of Chronic Illness Therapy: Fatigue) prior to Cycle 1 (baseline),4 (midpoint), and following cycle 6 (completion).
Conclusion:
PT directed home exercise program may improve CRF, functional decline, and QOL in elderly gynecologic oncology patients undergoing chemotherapy.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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North Carolina
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Raleigh, North Carolina, États-Unis, 27609
- Duke Raleigh Cancer Center
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Endometrial, Ovarian, Cervix, Vaginal Cancer Initiating Chemotherapy
- Age greater than or equal to 65yrs
- ECOG (Eastern Cooperative Oncology Group) performance status less than 3
- No current physical therapy intervention
- English speaking
Exclusion Criteria:
- Non-gynecologic malignancy
- Recurrent cancer
- Receiving radiation alone
- Gait or balance disturbance
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Intervention
Subjects randomized to intervention will receive Physical Therapist instructed exercise teaching.
They will receive a home exercise DVD and flip ring of exercises.
Subjects will be asked to perform home exercise 3 days weekly consisting of 13 strengthening/stretching exercises and 20 mins of aerobic exercise, walking or seated aerobics using ergometer.
Subjects will record their exercise on a log and return on day 1 of every cycle.
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Subjects randomized to intervention will receive Physical Therapist instructed exercise teaching.
They will receive a home exercise DVD and flip ring of exercises.
Subjects will be asked to perform home exercise 3 days weekly consisting of 13 strengthening/stretching exercises and 20 mins of aerobic exercise, walking or seated aerobics using ergometer.
Subjects will record their exercise on a log and return on day 1 of every cycle.
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Aucune intervention: Observation
Subjects randomized to observation will only have physical therapy assessment using the Berg Balance Test and 6min Walk Test at baseline and end point.
These subjects will not receive any exercise teaching.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Reduction in Cancer Related Fatigue (CRF)
Délai: Baseline, +/- 7days of 4th chemo cycle (mid point), +/- 7 days of 3 weeks after 6th cycle (end point)
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CRF will be evaluated using the FACIT-F tool.
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Baseline, +/- 7days of 4th chemo cycle (mid point), +/- 7 days of 3 weeks after 6th cycle (end point)
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Quality of Life Improvement (QOL)
Délai: Baseline, +/- 7days of cycle 4 of treatment (mid point), +/- 7 days of 3rd week after cycle 6 (end point)
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QOL will be evaluated using the NHANES and FACIT-F tools.
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Baseline, +/- 7days of cycle 4 of treatment (mid point), +/- 7 days of 3rd week after cycle 6 (end point)
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Reduction in Physical Functional Decline
Délai: Baseline and +/- 7days of 3 weeks post 6th cycle (end point)
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Physical function will be evaluated using the Berg Balance Test and 6 Min Walk Test
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Baseline and +/- 7days of 3 weeks post 6th cycle (end point)
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Alicia S. Johnson, ADN-RN, Duke University
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
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Pro00046121
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Essais cliniques sur Home Based Exercise
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