Ultrasound Assessment of a Physical Exercise in The Water in a Frail Population

NCT03955302 | Completed DMC

• 1 other identifier: 1557856842051
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

It is an experimental, longitudinal prospective, controlled trial. The project will be developed in the General University Hospital of Valencia (CHGUV), and the University of Valencia. Patients will be recruited from a previous cohort. The patients of this cohort will be contacted and proposed to participate. Those patients who accept, will be divided into the following experimental groups:

• Group 1: Patients in this group will perform the water exercise protocol, 3 times a week, for 12 weeks.
• Group 2: Patients in this group will not perform any type of exercise during the 12 weeks of the treatment. Variables related to muscular quality by ultrasound, frailty, physical function, independence in the activities of daily life, balance, cognitive function, quality of life and sleep, the social sphere will be evaluated, and the intensity of pain and fatigue, before and after12 weeks of intervention.

Conditions

Frailty Syndrome

Keywords

Frailty; Muscle Architecture; Ultrasound; Exercise Regimen; Aqua-Aerobics

Outcome Measures

Primary Outcomes (1)

• Muscle Architecture Improvement

  Muscle measurement with ultrasound before and after the intervention

  14 weeks

Study Arms (2)

Exercise

EXPERIMENTAL

Patients in this group will perform the water exercise protocol, 3 times a week, for 12 weeks.

Behavioral: Exercise

Control

NO INTERVENTION

Patients in this group will not perform any type of exercise during the 12 weeks of the treatment.

Interventions

Exercise BEHAVIORAL

There will be an intervention for 12 weeks. For exercises in the water, there will be an expert physiotherapist in the field of hydrotherapy that will guide the exercises in controlled sessions of approximately 45 minutes. Exercises of joint mobility, balance, strength and coordination with / without aquatic material will be included. At all times, qualified health personnel will monitor any symptom or sign that advises the removal of the subject of the study.

Exercise

Eligibility Criteria

• Age: 65 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age between 65 and 95 years, be physically inactive (\<150 min physical activity a week), meet 1 or more criteria of frailty according to Linda Fried criteria, signature of informed consent.

You may not qualify if:

• Institutionalized patients, life expectancy of less than 6 months for any reason, hospital admission in the last 3 months for any reason; major surgery in the last 6 months before the start of the study, oncological patient with active treatment with chemotherapy or radiotherapy; neurological or musculoskeletal pathology that contraindicates physical activity in water; severe disability (score below 15 points on the Barthel scale); severe cardiovascular disease, psychotic disorder or severe cognitive impairment.

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

Hospital General Universitario de Valencia

Valencia, 46014, Spain

Location

Related Publications (39)

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MeSH Terms

Conditions

Frailty

Interventions

Exercise

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Consuelo M Borras Blasco, PhD

  University of Valencia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2019
• First Posted: May 20, 2019
• Study Start: August 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: May 18, 2022

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)