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

NCT04179903 | Completed

• 1 other identifier: 45/18
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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

Conditions

Osteoporosis, Postmenopausal; Physical Activity

Keywords

osteoporosis; Gym Training; physical activity; home training

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Disability

  12 months

• Fear of falls

  12 months

• Walking

  12 months

• standing balance

  12 months

• Muscle force

  12 months

Study Arms (2)

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

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.

Other: Physical activity

Interventions

Physical activity OTHER

Physical Activity program is performed in a group in a gym and at home

Gym Trainer; Individual Home

Eligibility Criteria

• Age: 40 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead
• University of Bologna: collaborator

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location

MeSH Terms

Conditions

Osteoporosis, Postmenopausal; Motor Activity; Osteoporosis

Interventions

Exercise

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Claudio Ripamonti

  IOR

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2019
• First Posted: November 27, 2019
• Study Start: February 1, 2019
• Primary Completion: September 30, 2020
• Study Completion: June 30, 2021
• Last Updated: September 26, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)