Efficacy and Safety of the Exercise Program in Women With Post-menopausal Osteoporosis: Randomized Trial Comparing Gym Versus Home Training
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Istituto Ortopedico Rizzoli
- Enrollment
- 52
- Locations
- 1
- Primary Endpoint
- Quality of life questionnaire
Study Overview
Brief 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
Detailed Description
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:
- WHO Disability Assessment Schedule (WHODAS) which evaluates the six activity and participation domains of the International Classification of Functioning, Disability and Health (ICF): cognition, mobility, self-care, interacting with other people, life activities, participation.
- Fear of falls evaluated by the Falls Efficacy Scale International (FES-I);
- Walking (6-Minute Walk Test), standing balance (stability Index), muscle force (hand grip), postural alignment (occiput-wall distance) and joint mobility will be also evaluated as fundamental prerequisites of motor behavior;
- Body Mass index and body composition.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
- •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.
Arms & Interventions
Gym Trainer
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
Intervention: Physical activity (Other)
Individual Home
Physical Activity program is performed at home individually (Individual Home Training-IHT), without the supervision of a trainer during the exercise session.
Intervention: Physical activity (Other)
Outcomes
Primary Outcomes
Quality of life questionnaire
Time Frame: 12 months
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).
Secondary Outcomes
- Muscle force(12 months)
- joint mobility(12 months)
- Fear of falls(12 months)
- Disability(12 months)
- Walking(12 months)
- standing balance(12 months)
- Body Mass Index(12 months)