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Relationship Between the Risk of Falls and Frailty, and the Effect of a Physical Exercise Program on These Conditions in the Elderly: a Randomized Crossover Clinical Trial.

U

University of Valencia

Status

Enrolling

Conditions

Fall
Frail Elderly Syndrome

Treatments

Other: Therapeutic exercise program

Study type

Interventional

Funder types

Other

Identifiers

NCT05940779
H1504602336419

Details and patient eligibility

About

The goal of this randomized crossover clinical trial is to examine the effectiveness of a new therapeutic exercise program in elderly patients with risk of falls and physical fragility. The main questions it aims to answer are:

  • If the therapeutic exercise program proposed is a successful treatment for this kind of patients
  • If patients at risk of falls also suffer from pre-frailty or frailty, and if they can be treated together with the proposed therapy.

Participants will follow a program consisting of exercises to correct posture, gain strength and contribute to greater balance.

Researchers will compare the therapy and control groups to see if the program increases the percentage of muscle mass of participants, their mobility, balance, quality of life and if they reduce their Fried´s frailty criteria, fear of falling and falls compared to their usual physical activity.

Enrollment

40 estimated patients

Sex

All

Ages

65+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Community dwelling older adults.
  • Independent for ambulation.
  • With a cognitive state that do not prevent understand the researcher indications.
  • Not performing regular physical exercise (only basic activities of daily living, but no other type of intervention).

Exclusion criteria

  • Contraindication of physical exercise.
  • Evident impaired cognitive state.
  • Vestibular or central nervous system affection.
  • Can´t speak and understand spanish correctly.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

40 participants in 2 patient groups

Exercise group
Experimental group
Treatment:
Other: Therapeutic exercise program
Control group
No Intervention group

Trial contacts and locations

1

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Central trial contact

Belén Quel Tejón; José María Blasco Igual

Data sourced from clinicaltrials.gov

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