CompletedNot Applicable

Efficacy and Safety of the Physical Activity Program in Women With Post-menopausal Osteoporosis

Italy52 participantsStarted 2019-02-01

Plain-language summary

The study will be single blinded since professionals who will evaluate patients will not know to which exercise group patients have been assigned. The investigators hypothesize that effectiveness and safety of the exercise program are equal when administered as gym trainer or individual home trainer. However, the investigators expect differences in adherence among the two groups which may cause different impact on the outcome measures. Given the large amount of evidence on the efficacy of Physical Activity in women with Osteoporosis, the investigators considered it ethically unacceptable to advise a control group inactivity. On the other hand, it seemed particularly relevant for the purpose of addressing the advice to the improvement of the active lifestyle, to evaluate the impact of the ACTLIFE exercise program when administered as gym trainer or individual home trainer

Who can participate

Age range

40 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * signed informed consent * post menopausal women aged \>40 years (with or without history of fractures, with or without pharmacological therapy for OP) * lumbar spine or femur T-score ≤-2,5 * functional motor capacity normal or moderately reduced (Short Physical Performance Battery) * sedentary life style (having exercised less than 30 minutes per week in the last 6 months). Exclusion Criteria are: * secondary OP49, impairment of communicative and/or sensorial functions so severe to make impossible understanding or executing trainer's instructions (dementia, aphasia, blindness, deafness); * heart failure (NYHA class \>2); * unstable angina, pulmonary disease requiring oxygen therapy; * symptomatic peripheral arteriopathy; * myocardial infarction or hospital admission in the previous 6 months, * symptomatic orthostatic hypotension; * hypertension in poor pharmacologic control (diastolic \>95 mmHg, systolic \>160 mmHg), * previous implant of prosthesis at upper or lower limbs, * relevant neurological condition impairing motor or cognitive function, any other condition that the medical doctor (MD) considers to contraindicate the participation in an exercise program of moderate intensity.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Quality of life questionnaire

Timeframe: 12 months

Trial details

NCT IDNCT04179903

SponsorIstituto Ortopedico Rizzoli

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-09-30

View on ClinicalTrials.gov More Osteoporosis, Postmenopausal trials