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.

NCT05940779 | Unknown

• 1 other identifier: H1504602336419
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Frail Elderly Syndrome; Fall

Outcome Measures

Primary Outcomes (8)

• Timed Up and Go (TUG)

  Assessed before the first intervention (baseline).

• Timed Up and Go (TUG)

  Assessed after the first intervention (3 months later).

• Timed Up and Go (TUG)

  Assessed after the second intervention (3 months after the previous assessement).

• Timed Up and Go (TUG)

  Assessed after 3 months from the previous assessement.

• Fried frailty criteria

  The Fried frailty criteria are five: unintentional weight loss, muscular weakness, low resistance or tiredness, slow gait and low level of physical activity.

  Assessed before the first intervention (baseline).

• Fried frailty criteria

  The Fried frailty criteria are five: unintentional weight loss, muscular weakness, low resistance or tiredness, slow gait and low level of physical activity.

  Assessed after the first intervention (3 months later).

• Fried frailty criteria

  The Fried frailty criteria are five: unintentional weight loss, muscular weakness, low resistance or tiredness, slow gait and low level of physical activity.

  Assessed after the second intervention (3 months after the previous assessement).

• Fried frailty criteria

  The Fried frailty criteria are five: unintentional weight loss, muscular weakness, low resistance or tiredness, slow gait and low level of physical activity.

  Assessed after 3 months from the previous assessement.

Secondary Outcomes (18)

• Falls and their consequences

  Assessed before the first intervention (baseline).

• Falls and their consequences

  Every two weeks from date of the first assessement until the date of the study completion, an average of 1 year.

• Berg Balance Scale (BBS)

  Assessed before the first intervention (baseline).

• Berg Balance Scale (BBS)

  Assessed after the first intervention (3 months later).

• Berg Balance Scale (BBS)

  Assessed after the second intervention (3 months after the previous assessement).

Study Arms (2)

Exercise group

EXPERIMENTAL

Other: Therapeutic exercise program

Control group

NO INTERVENTION

Interventions

Therapeutic exercise program OTHER

The intervention is a therapeutic program composed of self-resisted strength exercises, balance training and exercises to improve posture.

Exercise group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

University of Valencia

Valencia, 46010, Spain

RECRUITING

Central Study Contacts

Belén Quel Tejón

CONTACT

675760137; bequelte@gmail.com

José María Blasco Igual

CONTACT

963983855; Jose.Maria.Blasco@uv.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2023
• First Posted: July 11, 2023
• Study Start: September 22, 2021
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: July 11, 2023

Record last verified: 2023-05

Locations

ES (1)