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.

Not Applicable

Recruiting

• Conditions: Fall; Frail Elderly Syndrome
• Interventions: Other: Therapeutic exercise program

• Registration Number: NCT05940779
• Lead Sponsor: University of Valencia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-22
• Status Verified: 2023-05
• Study First Submitted: 2023-05-31
• Study First Submitted QC: 2023-07-03
• Last Update Submitted: 2023-07-03
• Study First Posted: 2023-07-11
• Last Update Posted: 2023-07-11
• Primary Completion: 2024-09-30
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Exercise group	Therapeutic exercise program	-

Primary Outcome Measures

Name	Time	Method
Fried frailty criteria	Assessed after 3 months from the previous assessement.	The Fried frailty criteria are five: unintentional weight loss, muscular weakness, low resistance or tiredness, slow gait and low level of physical activity.
Timed Up and Go (TUG)	Assessed after 3 months from the previous assessement.

Secondary Outcome Measures

Name	Time	Method
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.	A follow-up made with phone calls.
Falls Efficacy Scale-International (FES-I)	Assessed after 3 months from the previous assessement.	From 16 to 64. Higher scores show more concern of falling.
European Quality of Life-5 Dimensions (EuroQol-5D)	Assessed after 3 months from the previous assessement.	It has two parts: The first one consists of questions about quality of life with scores from 0 to 1, higher if the quality of life of the patient is higher too.; The second one is a visual analogic scale (VAS) from 0 (worst quality of life) to 100 (bes quality of life).
Berg Balance Scale (BBS)	Assessed after 3 months from the previous assessement.	From 0 to 56. It shows a better balance when the score is higher.
Muscle mass	Assessed after 3 months from the previous assessement.	Assessed with and impedance scale.

Trial Locations

Locations (1)

University of Valencia; 🇪🇸 Valencia, Spain