Category
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Primary study
Registry of Trials»ISRCTN registry
Year
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2023
INTERVENTION: This is a single‐center, interventional, longitudinal, prospective, multi‐design study with a randomized controlled study (for intervention and sedentary participants) and a non‐randomized controlled study (for intervention/sedentary and regularly active participants) with between‐group (intervention, sedentary and active participants) and within‐subject measures (baseline, post‐intervention and 3 to 12‐month follow‐ups). The "Intention‐to‐treat" methodology will be adopted. For higher internal and external validity, the main confounders will be controlled for (e.g., matching participants, and counterbalancing measures) to decrease systematic secondary and error variance. A three‐component intervention will be offered: 1. A multicomponent, supervised exercise program with a 3‐month duration (12 weeks). The program will be designed and implemented by experts in Exercise and Sport Sciences and Sport and Exercise Medicine, following international recommendations for exercise in middle‐aged women. It will include training in aerobic cardio‐respiratory fitness, muscle resistance and other fitness functions such as flexibility and balance. 2. A simultaneous intervention for the self‐management of behavioral change based on the tenets of the HAPA model will be offered throughout the exercise program period. This intervention has been designed based on previously HAPA‐based interventions and is focused on improving the motivational determinants of intention and the volitional determinants for self‐regulated action and adherence. Its aim is to increase personal resources for long‐term, self‐managed adherence to the newly established lifestyle once the supervised exercise program is concluded. 3. A CONDITION: Health promotion in generally healthy women in early postmenopause (45‐65 years old) ; Not Applicable PRIMARY OUTCOME: Exercise behavior measured using the self‐reported International Physical Activity Questionnaire (IPAQ) at baseline, postintervention and follow‐ups SECONDARY OUTCOME: ; 1. HAPA constructs, measured using ad‐hoc self‐reports based on previously published measures Gholami & Schwarzer, 2014 at baseline, postintervention and follow‐ups; 2. Menopause‐related quality of life, measured using the generic 12‐Item Short Form Survey (SF‐12) and the specific validated Cervantes Scale at baseline, post‐intervention and follow‐ups; 3. Fitness and cardio‐respiratory and metabolic health, measured using structural (e.g., BMI) and functional (e.g., EUROFIT) indicators at baseline, postintervention and follow‐ups; 4. Perceived health status and health‐related lifestyle, measured using a self‐report (e.g., self‐reported health status and processes: EQ‐SD, Rabin & Charro, 2001); health‐related lifestyle: healthy lifestyle indicators, Godoy & Godoy‐Izquierdo, 2006) at baseline, postintervention and follow‐ups; 5. Sociodemographic and clinical data, measured using a personal data form and medical anamnesis at baseline; INCLUSION CRITERIA: For all study groups: 1. Postmenopausal women between 45 and 65 years with no menses for 12 months or more until 10 years of postmenopause, based on Stages of Reproductive Aging Workshop STRAW +10 criteria 2. Non‐use of hormone therapy in at least the three months before recruitment 3. Providing a signed consent form for voluntary participation 4. Speaking and reading Spanish with proficiency 5. Not suffering from any severe physical or mental disease that would seriously deteriorate functioning, impede participation in exercise based on medical criteria or introduce bias in responses. For intervention and sedentary control groups: 1. Not exercising on a regular basis, independently of daily physical activity, e.g., walking for transportation, for at least the last 12 months For the active control group: 1. Exercising on a regular basis reaching international recommended levels for at lea
Epistemonikos ID: 1ea5362cb5732d67f9de5989175454a15c840e40
First added on: Aug 26, 2024