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.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Frail Elderly Syndrome
- Sponsor
- University of Valencia
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Fried frailty criteria
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
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.
Outcomes
Primary Outcomes
Fried frailty criteria
Time Frame: 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)
Time Frame: Assessed after 3 months from the previous assessement.
Secondary Outcomes
- 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.)
- Falls Efficacy Scale-International (FES-I)(Assessed after 3 months from the previous assessement.)
- European Quality of Life-5 Dimensions (EuroQol-5D)(Assessed after 3 months from the previous assessement.)
- Berg Balance Scale (BBS)(Assessed after 3 months from the previous assessement.)
- Muscle mass(Assessed after 3 months from the previous assessement.)