EFFECT OF FLOW RESTRICTION ON BONE QUALITY WITHIN A MULTICOMPONENT EXERCISE PROGRAM FOR OLDER WOMEN WITH OSTEOPOROSIS.

Summary

HYPOTHESIS:

\- A multicomponent exercise program where strength exercises are performed with blood flow restriction obtains better values in densitometry and bone mass of osteoporotic patients with respect to the same multicomponent exercise program where strength is worked without flow restriction.

INTERVENTION:

The recruitment of the population will be carried out between July and November 2021, with the collaboration of the Consorci Sanitari de Terrassa (CST), which brings together a hospital center and different primary care centers (CAP). The primary care physicians and rheumatologists of the CST will receive an e-mail from the hospital management, informing them of the study to be carried out so that, if they consider it appropriate, they can inform their patients.

Intervention of the intervention and control group:

Each volunteer will be assigned to an intervention group either to the control group (CG) or experimental group (EG).

The control group and intervention group will receive the same multicomponent exercise program, based on specific literature for being an effective, safe and feasible training for both elderly people {{2091 Bouaziz, Walid 2016;}} {{2092 Fragala,M. S. 2019;}}, with or without frailty {{2093 Cadore, Eduardo L 2014;}} {{2094 Casas-Herrero, Alvaro 2019;}} {{2088 Fernández-García, Ángel Iván 2020;}} and/or with osteoporosis {{2089 Moradell, Ana 2020;}}. The main difference between both groups is that the experimental group (EG) will perform the strength exercises with flow restriction (BFR) while the control group (CG) will not have any restriction.

The periodicity of both groups will be 2 sessions per week, with a duration of 65 minutes per session and the duration of the intervention of 6 months and a follow-up 12 months after the beginning of the intervention (see scheme).

The training will be supervised at all times by a physiotherapist with more than 10 years of experience in multicomponent exercise. The sessions will include both limb and trunk work and will have a clear functional objective, focusing on activities of daily living (ADL). Each session will work on all the basic physical abilities (strength, balance, endurance, flexibility and coordination) and will be divided into:

* 10 minutes of initial warm-up. This is divided into 8 minutes walking on a treadmill or cyclohergometer with an intensity corresponding to 30% of heart rate reserve. Followed by 2 minutes of active mobilizations in both upper and lower extremities.
* 20 minutes of strength exercises. These will be interspersed with the rest of the exercises and will include the different extremities and trunk. During the first month, training will be carried out with loads corresponding to 20% of 1 repetition maximum (RM) and from the second month onwards it will be increased to 30-35% of 1 RM.
* 10 minutes of resistance exercises. These exercises will be interspersed with the rest to make the session much more enjoyable.
* 10 minutes of coordination and balance exercises. These exercises will be interspersed with the rest of the activities.
* 5 minutes of flexibility. These exercises will be performed interspersed with the strength and endurance exercises.
* 5 minutes of return to calm and relaxation. To facilitate the monitoring of the researcher who will apply the intervention, each group will be subdivided into smaller groups (ratio of 5 subjects per researcher).

Conditions

• Osteoporosis
• Osteoporosis, Postmenopausal
• Bone Diseases
• Exercise

Interventions

OTHER

Multicomponent Exercise with Blood Flow Restriction

* 10 minutes of initial warm-up. * 20 minutes of strength exercises. * 10 minutes of resistance exercises. * 10 minutes of coordination and balance exercises. * 5 minutes of flexibility. * 5 minutes of return to calm and relaxation. All of this multicomponent training will be performed with blood flow restriction.

OTHER

Multicomponent Exercise without Blood Flow Restriction

* 10 minutes of initial warm-up. * 20 minutes of strength exercises. * 10 minutes of resistance exercises. * 10 minutes of coordination and balance exercises. * 5 minutes of flexibility. * 5 minutes of return to calm and relaxation. All of this multicomponent training will be performed without blood flow restriction.

Sponsors & Collaborators

• Universitat Internacional de Catalunya

  lead OTHER

Principal Investigators

• Carlos López-de-Celis, PhD · Universitat Internacional de Catalunya

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

60 Years

Max Age

75 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-07-01

Primary Completion

2021-11-01

Completion

2021-12-01