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

NCT04760145 | Unknown DMC

• 1 other identifier: CBAS-2021-11Z
• Study Type: interventional
• Target: 94
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Exercise; Osteoporosis; Blood Flow Restriction

Outcome Measures

Primary Outcomes (3)

• Dual-energy X-ray absorptiometry (DEXA)

  s a test that measures the density of your bones. The DEXA scan is an x-ray scan that uses a small amount of radiation to take pictures of different bones. These pictures are used to measure the density of the bones at the spine and hip in this case.

  Change between baseline(immediately before intervention) and post intervention (6 months after baseline); Change between baseline and final of the study (12 months after baseline)

• Quantitative Ultrasound (QUS)

  is a relatively recent and noninvasive method of estimating bone mineral status at peripheral skeleton. In addition to bone density, QUS methods provide some structural information, which may be important in determining the fracture risk

  Change between baseline(immediately before intervention) and 2, 4, 6 (post intervention), 8, 10 and 12 (final of the study) months after baseline

• Osteoporosis self efficacy scale (OSES)

  o measure confidence for adopting behavior change regarding calcium intake (6 items) and exercise (6 items). Participants are asked, "If it were recommended that you do any of the following THIS WEEK, how confident or certain would you be that you could:" and then presented with a list of examples such as: "Do exercises even if they are difficult" and "Obtain foods that give an adequate amount of calcium even when they are not readily available." Participants then respond on a 10-point Likert-type scale of 0 to 10 (0=not confident at all, 10=very confident). For each participant, an Exercise Score is calculated by averaging the responses to the 6 exercise-related items and multiplying by 10, and a Calcium Score is derived by averaging the responses to the 6 calcium-related items and multiplying by 10 (range: 0-100). Cronbach's alpha coefficients ranged from 0.90 to 0.94

  Change between baseline(immediately before intervention) and 2, 4, 6 (post intervention), 8, 10 and 12 (final of the study) months after baseline

Secondary Outcomes (11)

• Senior Fitness Test

  Change between baseline(immediately before intervention) and post intervention (6 months after baseline); Change between baseline and final of the study (12 months after baseline)

• EUROFIT Fitness test battery

  Change between baseline(immediately before intervention) and post intervention (6 months after baseline); Change between baseline and final of the study (12 months after baseline)

• Physical Activity Scale for the Elderly (PASE)

  Change between baseline(immediately before intervention) and post intervention (6 months after baseline); Change between baseline and final of the study (12 months after baseline)

• Elderly EXERNET Physical Activity Questionnaire (EEPAQ)

  Change between baseline(immediately before intervention) and post intervention (6 months after baseline); Change between baseline and final of the study (12 months after baseline)

• 6-min-walk test

  Change between baseline(immediately before intervention) and post intervention (6 months after baseline); Change between baseline and final of the study (12 months after baseline)

Study Arms (2)

Intervention Group

EXPERIMENTAL

Multicomponent exercise with blood flow restriction

Other: Multicomponent Exercise with Blood Flow Restriction

Control Group

ACTIVE COMPARATOR

Multicomponent exercise without blood flow restriction

Other: Multicomponent Exercise without Blood Flow Restriction

Interventions

Multicomponent Exercise with Blood Flow Restriction OTHER

* 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.

Intervention Group

Multicomponent Exercise without Blood Flow Restriction OTHER

* 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.

Control Group

Eligibility Criteria

• Age: 60 Years - 75 Years
• Gender Eligibility Details: postmenopausal women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A woman between 60 and 75 years of age with a medical diagnosis of osteoporosis by means of a femur or lumbar densitometry of less than 2.5 standard deviations (SD) of peak bone mass.
• No history of previous fracture in the last 10 years.

You may not qualify if:

• Secondary osteoporosis.
• Having suffered a bone fracture in the last year.
• Present primary osteoporosis but who presented juvenile osteoporosis in adolescence or youth.
• Uncontrolled arterial hypertension.
• Severe acute respiratory failure.
• Uncontrolled orthostatic hypotension.
• Diabetes mellitus with acute decompensation or uncontrolled hypoglycemia.
• Endocrine, hematological and other associated rheumatic diseases.
• Mental health problems (schizophrenia, dementia, depression, etc.) or not being in full mental capacity.
• Patients with pharmacological treatments of glucocorticoids, anticoagulants and/or diuretics.
• Patients with coagulation problems or previous cardiac pathology.
• People with a body mass index (BMI) equal to or higher than 30.
• Subjects who present a systemic disease or any other pathology in which therapeutic exercise could be contraindicated.

Sponsors & Collaborators

• Universitat Internacional de Catalunya: lead

MeSH Terms

Conditions

Osteoporosis; Osteoporosis, Postmenopausal; Bone Diseases; Motor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

• Carlos López-de-Celis, PhD

  Universitat Internacional de Catalunya

  STUDY CHAIR

Central Study Contacts

Albert Pérez-Bellmunt, PhD

CONTACT

+34636817297; aperez@uic.es

Jacobo Rodríguez-Sanz, PhD

CONTACT

+34636136789; jrodriguezs@uic.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 15, 2021
• First Posted: February 18, 2021
• Study Start: July 1, 2021
• Primary Completion: November 1, 2021
• Study Completion: December 1, 2021
• Last Updated: February 18, 2021

Record last verified: 2021-02