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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05940779
Other study ID # H1504602336419
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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. - CanĀ“t speak and understand spanish correctly.

Study Design


Related Conditions & MeSH terms


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.
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