Osteoporosis, PostmenopausalACTLIFENCT04179903
Efficacy and Safety of the Physical Activity Program in Women With Post-menopausal Osteoporosis
A study testing Physical activity in people with Osteoporosis, Postmenopausal and Physical Activity, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- Conditions the study is for
- Osteoporosis, Postmenopausal, Physical Activity
- What is being tested?
- Physical activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2019to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of the Exercise Program in Women With Post-menopausal Osteoporosis: Randomized Trial Comparing Gym Versus Home Training
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
Read the 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.
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.
- Conditions
- Osteoporosis, Postmenopausal, Physical Activity
- Being tested
- Physical activity
- Keywords
- osteoporosis, Gym Training, physical activity, home training
- Medical subject headings
- Osteoporosis, Postmenopausal, Motor Activity, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activityOther
Physical Activity program is performed in a group in a gym and at home
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Physical activity |
| 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. Receives: Other: Physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 months
Secondary outcomes (7)
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)
Measured: 12 months
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)
Measured: 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.
Measured: 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
Measured: 12 months
Muscle force
Hand grip (KG)
Measured: 12 months
joint mobility
Hip range of motion in degree, knee range of motion in degree, shoulder range of motion in degree
Measured: 12 months
Body Mass Index
Weight and height will be combined to report BMI in kg/m^2
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2019
- Study start1 Feb 2019
- Primary completion30 Sep 2020
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoporosis, PostmenopausalStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bologna
- Responsible party
- Sponsor
- Investigators
- Claudio Ripamonti, Principal investigator, IOR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04179903
- Sponsor's protocol ID
- 45/18
- Acronym
- ACTLIFE
- Status last verified
- Sep 2023
- First submitted
- 4 Jun 2019
- Last updated
- 26 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of the Exercise Program in Women With Post-menopausal Osteoporosis: Randomized Trial Comparing Gym Versus Home Training
- ClinicalTrials.gov ID
- NCT04179903
- Acronym / sponsor ID
- ACTLIFE / 45/18
- Conditions
- Osteoporosis, Postmenopausal, Physical Activity
- Keywords
- osteoporosis, Gym Training, physical activity, home training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Collaborators
- University of Bologna
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 27 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gym Trainer | Active comparator | Other: Physical activityPhysical 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 |
| Individual Home | Active comparator | Other: Physical activityPhysical Activity program is performed at home individually (Individual Home Training-IHT), without the supervision of a trainer during the exercise session. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (9 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activityPhysical Activity program is performed in a group in a gym and at home | Other | Gym Trainer, Individual Home |
Primary outcome
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).
7 secondary outcomes
Disability
Time frame: 12 months
Fear of falls
Time frame: 12 months
Walking
Time frame: 12 months
standing balance
Time frame: 12 months
Muscle force
Time frame: 12 months
joint mobility
Time frame: 12 months
Body Mass Index
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudio Ripamonti principal investigator
IOR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity in people with Osteoporosis, Postmenopausal and Physical Activity, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life questionnaire (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2023.