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.

Fall Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05940779
• Other study ID #: H1504602336419
• Status: Recruiting
• Phase: N/A
• Start date: September 22, 2021
• Est. completion date: September 30, 2024

Study information

• Verified date: May 2023
• Source: University of Valencia
• Contact: Belén Quel Tejón
• Phone: 675760137
• Email: bequelte[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fall
• Frail Elderly Syndrome
• Frailty

Intervention

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

Locations

Country	Name	City	State
Spain	University of Valencia	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
University of Valencia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Timed Up and Go (TUG)		Assessed before the first intervention (baseline).
Primary	Timed Up and Go (TUG)		Assessed after the first intervention (3 months later).
Primary	Timed Up and Go (TUG)		Assessed after the second intervention (3 months after the previous assessement).
Primary	Timed Up and Go (TUG)		Assessed after 3 months from the previous assessement.
Primary	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).
Primary	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).
Primary	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).
Primary	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	Falls and their consequences	The number of falls in the last year will be asked.	Assessed before the first intervention (baseline).
Secondary	Falls and their consequences	A follow-up made with phone calls.	Every two weeks from date of the first assessement until the date of the study completion, an average of 1 year.
Secondary	Berg Balance Scale (BBS)	From 0 to 56. It shows a better balance when the score is higher.	Assessed before the first intervention (baseline).
Secondary	Berg Balance Scale (BBS)	From 0 to 56. It shows a better balance when the score is higher.	Assessed after the first intervention (3 months later).
Secondary	Berg Balance Scale (BBS)	From 0 to 56. It shows a better balance when the score is higher.	Assessed after the second intervention (3 months after the previous assessement).
Secondary	Berg Balance Scale (BBS)	From 0 to 56. It shows a better balance when the score is higher.	Assessed after 3 months from the previous assessement.
Secondary	Falls Efficacy Scale-International (FES-I)	From 16 to 64. Higher scores show more concern of falling.	Assessed before the first intervention (baseline).
Secondary	Falls Efficacy Scale-International (FES-I)	From 16 to 64. Higher scores show more concern of falling.	Assessed after the first intervention (3 months later).
Secondary	Falls Efficacy Scale-International (FES-I)	From 16 to 64. Higher scores show more concern of falling.	Assessed after the second intervention (3 months after the previous assessement).
Secondary	Falls Efficacy Scale-International (FES-I)	From 16 to 64. Higher scores show more concern of falling.	Assessed after 3 months from the previous assessement.
Secondary	European Quality of Life-5 Dimensions (EuroQol-5D)	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).	Assessed before the first intervention (baseline).
Secondary	European Quality of Life-5 Dimensions (EuroQol-5D)	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).	Assessed after the first intervention (3 months later).
Secondary	European Quality of Life-5 Dimensions (EuroQol-5D)	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).	Assessed after the second intervention (3 months after the previous assessement).
Secondary	European Quality of Life-5 Dimensions (EuroQol-5D)	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).	Assessed after 3 months from the previous assessement.
Secondary	Muscle mass	Assessed with and impedance scale.	Assessed before the first intervention (baseline).
Secondary	Muscle mass	Assessed with and impedance scale.	Assessed after the first intervention (3 months later).
Secondary	Muscle mass	Assessed with and impedance scale.	Assessed after the second intervention (3 months after the previous assessement).
Secondary	Muscle mass	Assessed with and impedance scale.	Assessed after 3 months from the previous assessement.