Back to resultsRelationship 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.
Primary Purpose
Frail Elderly Syndrome, Fall
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Therapeutic exercise program
Sponsored by
About this trial
This is an interventional treatment trial for Frail Elderly Syndrome
Eligibility Criteria
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.
Sites / Locations
- University of ValenciaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Exercise group
Control group
Arm Description
Outcomes
Primary Outcome Measures
Timed Up and Go (TUG)
Timed Up and Go (TUG)
Timed Up and Go (TUG)
Timed Up and Go (TUG)
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.
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.
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.
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.
Secondary Outcome Measures
Falls and their consequences
The number of falls in the last year will be asked.
Falls and their consequences
A follow-up made with phone calls.
Berg Balance Scale (BBS)
From 0 to 56. It shows a better balance when the score is higher.
Berg Balance Scale (BBS)
From 0 to 56. It shows a better balance when the score is higher.
Berg Balance Scale (BBS)
From 0 to 56. It shows a better balance when the score is higher.
Berg Balance Scale (BBS)
From 0 to 56. It shows a better balance when the score is higher.
Falls Efficacy Scale-International (FES-I)
From 16 to 64. Higher scores show more concern of falling.
Falls Efficacy Scale-International (FES-I)
From 16 to 64. Higher scores show more concern of falling.
Falls Efficacy Scale-International (FES-I)
From 16 to 64. Higher scores show more concern of falling.
Falls Efficacy Scale-International (FES-I)
From 16 to 64. Higher scores show more concern of falling.
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).
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).
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).
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).
Muscle mass
Assessed with and impedance scale.
Muscle mass
Assessed with and impedance scale.
Muscle mass
Assessed with and impedance scale.
Muscle mass
Assessed with and impedance scale.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05940779
Brief 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.
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.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 22, 2021 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Valencia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frail Elderly Syndrome, Fall
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Exercise group
Arm Type
Experimental
Arm Title
Control group
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Therapeutic exercise program
Intervention Description
The intervention is a therapeutic program composed of self-resisted strength exercises, balance training and exercises to improve posture.
Primary Outcome Measure Information:
Title
Timed Up and Go (TUG)
Time Frame
Assessed before the first intervention (baseline).
Title
Timed Up and Go (TUG)
Time Frame
Assessed after the first intervention (3 months later).
Title
Timed Up and Go (TUG)
Time Frame
Assessed after the second intervention (3 months after the previous assessement).
Title
Timed Up and Go (TUG)
Time Frame
Assessed after 3 months from the previous assessement.
Title
Fried frailty criteria
Description
The Fried frailty criteria are five: unintentional weight loss, muscular weakness, low resistance or tiredness, slow gait and low level of physical activity.
Time Frame
Assessed before the first intervention (baseline).
Title
Fried frailty criteria
Description
The Fried frailty criteria are five: unintentional weight loss, muscular weakness, low resistance or tiredness, slow gait and low level of physical activity.
Time Frame
Assessed after the first intervention (3 months later).
Title
Fried frailty criteria
Description
The Fried frailty criteria are five: unintentional weight loss, muscular weakness, low resistance or tiredness, slow gait and low level of physical activity.
Time Frame
Assessed after the second intervention (3 months after the previous assessement).
Title
Fried frailty criteria
Description
The Fried frailty criteria are five: unintentional weight loss, muscular weakness, low resistance or tiredness, slow gait and low level of physical activity.
Time Frame
Assessed after 3 months from the previous assessement.
Secondary Outcome Measure Information:
Title
Falls and their consequences
Description
The number of falls in the last year will be asked.
Time Frame
Assessed before the first intervention (baseline).
Title
Falls and their consequences
Description
A follow-up made with phone calls.
Time Frame
Every two weeks from date of the first assessement until the date of the study completion, an average of 1 year.
Title
Berg Balance Scale (BBS)
Description
From 0 to 56. It shows a better balance when the score is higher.
Time Frame
Assessed before the first intervention (baseline).
Title
Berg Balance Scale (BBS)
Description
From 0 to 56. It shows a better balance when the score is higher.
Time Frame
Assessed after the first intervention (3 months later).
Title
Berg Balance Scale (BBS)
Description
From 0 to 56. It shows a better balance when the score is higher.
Time Frame
Assessed after the second intervention (3 months after the previous assessement).
Title
Berg Balance Scale (BBS)
Description
From 0 to 56. It shows a better balance when the score is higher.
Time Frame
Assessed after 3 months from the previous assessement.
Title
Falls Efficacy Scale-International (FES-I)
Description
From 16 to 64. Higher scores show more concern of falling.
Time Frame
Assessed before the first intervention (baseline).
Title
Falls Efficacy Scale-International (FES-I)
Description
From 16 to 64. Higher scores show more concern of falling.
Time Frame
Assessed after the first intervention (3 months later).
Title
Falls Efficacy Scale-International (FES-I)
Description
From 16 to 64. Higher scores show more concern of falling.
Time Frame
Assessed after the second intervention (3 months after the previous assessement).
Title
Falls Efficacy Scale-International (FES-I)
Description
From 16 to 64. Higher scores show more concern of falling.
Time Frame
Assessed after 3 months from the previous assessement.
Title
European Quality of Life-5 Dimensions (EuroQol-5D)
Description
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).
Time Frame
Assessed before the first intervention (baseline).
Title
European Quality of Life-5 Dimensions (EuroQol-5D)
Description
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).
Time Frame
Assessed after the first intervention (3 months later).
Title
European Quality of Life-5 Dimensions (EuroQol-5D)
Description
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).
Time Frame
Assessed after the second intervention (3 months after the previous assessement).
Title
European Quality of Life-5 Dimensions (EuroQol-5D)
Description
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).
Time Frame
Assessed after 3 months from the previous assessement.
Title
Muscle mass
Description
Assessed with and impedance scale.
Time Frame
Assessed before the first intervention (baseline).
Title
Muscle mass
Description
Assessed with and impedance scale.
Time Frame
Assessed after the first intervention (3 months later).
Title
Muscle mass
Description
Assessed with and impedance scale.
Time Frame
Assessed after the second intervention (3 months after the previous assessement).
Title
Muscle mass
Description
Assessed with and impedance scale.
Time Frame
Assessed after 3 months from the previous assessement.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Belén Quel Tejón
Phone
675760137
Email
bequelte@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
José María Blasco Igual
Phone
963983855
Email
Jose.Maria.Blasco@uv.es
Facility Information:
Facility Name
University of Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
José María Blasco Igual
Phone
963983855
Email
Jose.Maria.Blasco@uv.es
12. IPD Sharing Statement
Learn more about this trial
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.
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