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

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

Study Overview

• Status: Completed
• Conditions: Physical Activity; Osteoporosis, Postmenopausal
• Intervention / Treatment: Other: Physical activity

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 Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Bologna, Italy, 40136
    • Istituto Ortopedico Rizzoli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Other: Physical activity; Physical Activity program is performed in a group in a gym and at home
Active Comparator: Individual Home; Physical Activity program is performed at home individually (Individual Home Training-IHT), without the supervision of a trainer during the exercise session.	Other: Physical activity; Physical Activity program is performed in a group in a gym and at home

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Istituto Ortopedico Rizzoli
• Collaborators: University of Bologna
• Investigators: Principal Investigator: Claudio Ripamonti, IOR

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2019
• Primary Completion (Actual): September 30, 2020
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: June 4, 2019
• First Submitted That Met QC Criteria: November 26, 2019
• First Posted (Actual): November 27, 2019

Study Record Updates

• Last Update Posted (Actual): September 26, 2023
• Last Update Submitted That Met QC Criteria: September 22, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: physical activity; osteoporosis; home training; Gym Training
• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoporosis; Osteoporosis, Postmenopausal
• Other Study ID Numbers: 45/18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No