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| Name | Class |
|---|---|
| University of Bologna | OTHER |
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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
The present study is carried out within the project "Physical ACTivity: the tool to improve the quality of LIFE in osteoporosis people" (ACTLIFE) and is funded within the Erasmus Plus Sport program (Grant Agreement N2017-2128/001-001).
It is aimed at evaluating differences in efficacy and safety of a PA program specifically designed for improving physical function and, here in after, QoL in post menopausal women with Osteoporosis (T-score <-2,5) under usual pharmacological treatment, when administered as gyms as group training (GGT) or Individual Home Training IHT. During the study patients will be recommended to maintain their usual pharmacological treatment for OP, as prescribed.
The primary objective of the study is to compare modifications of QoL measured with the Short Osteoporosis Quality of Life Questionnaire (ECOS-16) induced by the ACTLIFE exercise programme when administered as IHT or GGT. ECOS-16 is a specific-disease instrument with the purpose to measure the health related QoL (HRQoL) in post menopausal women with OP.
The secondary objectives of the study are to investigate differences between IHT and GGT on domains which are considered to be determinants of QoL:
The adherence of each patient to the exercise program will be monitored. The adherence will be measured as percent of exercise sessions actually performed /total number of scheduled exercise sessions. The investigators hypothesize that effectiveness and safety of the exercise program are equal when administered as GGT or IHT. However, the investigators expect differences in adherence among the two groups which may cause different impact on the outcome measures. In the context of the evaluation of adherence to the program, the satisfaction of the participants for the ACTLIFE program administered as GGT or IHT at the end of the 12 months of exercise will be evaluated with a specific questionnaire based on 7-point Likert scale and the reasons of abandoning the exercise program (question with structured answers). Education attainment, work activity, marital status and home-gym distance will be also recorded since recognized to influence the adherence in an exercise program.
The ultimate goal of the ACTLIFE exercise program is to increase physical activity in a sedentary population. The exercise program, through its beneficial effects on health, is expected to generate a virtuous circle of greater activity and participation. In this context, to evaluate differences between GGT or IHT, the investigators introduced in the study protocol the Physical Activity Scale for the Elderly (PASE). PASE is an easily scored survey designed specifically to measure the weekly physical activity in adult and aged population. Its score combines information on leisure, household and occupational activity.
RT with two parallel groups: in the first group the 12-month ACTLIFE program is performed as IHT, while in the second as GGT. The study will be single blinded since professionals who will evaluate patients will not know to which exercise group they have been assigned. Patients will be assessed at baseline and after 6 and 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gym Trainer | Active Comparator | Physical Activity program is performed in a group in a gym (Gym Group Training-GGT), with activity sessions conducted by a trainer graduated in Science and Techniques of Preventive and Adapted Physical Activity |
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| Individual Home | Active Comparator | Physical Activity program is performed at home individually (Individual Home Training-IHT), without the supervision of a trainer during the exercise session. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical activity | Other | Physical Activity program is performed in a group in a gym and at home |
|
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life questionnaire | Assessment of health related quality of life in osteoporosis - ECOS-16 questionnaire measures the HRQoL in postmenopausal women with osteoporosis. The 16 items are divided into 4 dimensions. The score of each item ranges from 1 to 5. A single summary score obtained from the arithmetic mean of the answered items, so the total score ranges from 1 (best HRQoL) to 5 (worst HRQoL). | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Disability | WHODAS has six domains of life
| 12 months |
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Inclusion Criteria:
Exclusion Criteria are:
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| Name | Affiliation | Role |
|---|---|---|
| Claudio Ripamonti | IOR | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituto Ortopedico Rizzoli | Bologna | 40136 | Italy |
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| ID | Term |
|---|---|
| D015663 | Osteoporosis, Postmenopausal |
| D009043 | Motor Activity |
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Fear of falls |
Falls Efficacy Scale International - FES-I The score contains 16 items scored on a four point scale (1= not all concerned to 4= very concerned To calculate the FES-I or Short FES-I score when all items are completed, simply add the scores for each item together to give a total that ranges as follows: Minimum 16 (no concern about falling) to maximum 64 (severe concern about falling) |
| 12 months |
| Walking | 6-Minute Walk Test The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance (m) covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. An increase in the distance walked indicates improvement in basic mobility. | 12 months |
| standing balance | Standing balance will be estimated by the validated Stability Index for both right and left lower limb. It evaluates proprioceptive control, visual dependence, and the risk of fall and injury. The Stability Index is a score (0-100 %). 100% is high | 12 months |
| Muscle force | Hand grip (KG) | 12 months |
| joint mobility | Hip range of motion in degree, knee range of motion in degree, shoulder range of motion in degree | 12 months |
| Body Mass Index | Weight and height will be combined to report BMI in kg/m^2 | 12 months |
| D009750 |
| Nutritional and Metabolic Diseases |
| D001519 | Behavior |