Physical Activity Clinical Trial
— ACTLIFEOfficial title:
Efficacy and Safety of the Exercise Program in Women With Post-menopausal Osteoporosis: Randomized Trial Comparing Gym Versus Home Training
NCT number | NCT04179903 |
Other study ID # | 45/18 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | February 1, 2019 |
Est. completion date | June 30, 2021 |
Verified date | September 2023 |
Source | Istituto Ortopedico Rizzoli |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 52 |
Est. completion date | June 30, 2021 |
Est. primary completion date | September 30, 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 40 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Italy | Istituto Ortopedico Rizzoli | Bologna |
Lead Sponsor | Collaborator |
---|---|
Istituto Ortopedico Rizzoli | University of Bologna |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | Disability | WHODAS has six domains of life
Cognition understanding and communicating Mobility Self-care Getting along Life activities Summing of recorded item scores within each domain after the converting the summary score into a metric raging from 0 to 100 ( 0 = no disability - 100 = full disability) |
12 months | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Muscle force | Hand grip (KG) | 12 months | |
Secondary | joint mobility | Hip range of motion in degree, knee range of motion in degree, shoulder range of motion in degree | 12 months | |
Secondary | Body Mass Index | Weight and height will be combined to report BMI in kg/m^2 | 12 months |
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