## Protocol Section
### Identification Module
**NCT ID:** 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.

#### Organization Study ID Info
**ID:** H1504602336419
#### Organization
**Class:** OTHER
**Full Name:** University of Valencia
### Status Module
#### Completion Date
**Date:** 2024-09-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-07-11

**Type:** ACTUAL

**Last Update Submit Date:** 2023-07-03

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-09-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2021-09-22

**Type:** ACTUAL

**Status Verified Date:** 2023-05

#### Study First Post Date
**Date:** 2023-07-11
**Type:** ACTUAL
**Study First Submit Date:** 2023-05-31
**Study First Submit QC Date:** 2023-07-03
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Valencia

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Frail Elderly Syndrome

- Fall

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** CROSSOVER

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 40

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Other: Therapeutic exercise program

**Label:** Exercise group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Label:** Control group

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Exercise group

**Description:** The intervention is a therapeutic program composed of self-resisted strength exercises, balance training and exercises to improve posture.

**Name:** Therapeutic exercise program

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Measure:** Timed Up and Go (TUG)

**Time Frame:** Assessed before the first intervention (baseline).

**Measure:** Timed Up and Go (TUG)

**Time Frame:** Assessed after the first intervention (3 months later).

**Measure:** Timed Up and Go (TUG)

**Time Frame:** Assessed after the second intervention (3 months after the previous assessement).

**Measure:** Timed Up and Go (TUG)

**Time Frame:** Assessed after 3 months from the previous assessement.

**Description:** The Fried frailty criteria are five: unintentional weight loss, muscular weakness, low resistance or tiredness, slow gait and low level of physical activity.

**Measure:** Fried frailty criteria

**Time Frame:** Assessed before the first intervention (baseline).

**Description:** The Fried frailty criteria are five: unintentional weight loss, muscular weakness, low resistance or tiredness, slow gait and low level of physical activity.

**Measure:** Fried frailty criteria

**Time Frame:** Assessed after the first intervention (3 months later).

**Description:** The Fried frailty criteria are five: unintentional weight loss, muscular weakness, low resistance or tiredness, slow gait and low level of physical activity.

**Measure:** Fried frailty criteria

**Time Frame:** Assessed after the second intervention (3 months after the previous assessement).

**Description:** The Fried frailty criteria are five: unintentional weight loss, muscular weakness, low resistance or tiredness, slow gait and low level of physical activity.

**Measure:** Fried frailty criteria

**Time Frame:** Assessed after 3 months from the previous assessement.

#### Secondary Outcomes

**Description:** The number of falls in the last year will be asked.

**Measure:** Falls and their consequences

**Time Frame:** Assessed before the first intervention (baseline).

**Description:** A follow-up made with phone calls.

**Measure:** Falls and their consequences

**Time Frame:** Every two weeks from date of the first assessement until the date of the study completion, an average of 1 year.

**Description:** From 0 to 56. It shows a better balance when the score is higher.

**Measure:** Berg Balance Scale (BBS)

**Time Frame:** Assessed before the first intervention (baseline).

**Description:** From 0 to 56. It shows a better balance when the score is higher.

**Measure:** Berg Balance Scale (BBS)

**Time Frame:** Assessed after the first intervention (3 months later).

**Description:** From 0 to 56. It shows a better balance when the score is higher.

**Measure:** Berg Balance Scale (BBS)

**Time Frame:** Assessed after the second intervention (3 months after the previous assessement).

**Description:** From 0 to 56. It shows a better balance when the score is higher.

**Measure:** Berg Balance Scale (BBS)

**Time Frame:** Assessed after 3 months from the previous assessement.

**Description:** From 16 to 64. Higher scores show more concern of falling.

**Measure:** Falls Efficacy Scale-International (FES-I)

**Time Frame:** Assessed before the first intervention (baseline).

**Description:** From 16 to 64. Higher scores show more concern of falling.

**Measure:** Falls Efficacy Scale-International (FES-I)

**Time Frame:** Assessed after the first intervention (3 months later).

**Description:** From 16 to 64. Higher scores show more concern of falling.

**Measure:** Falls Efficacy Scale-International (FES-I)

**Time Frame:** Assessed after the second intervention (3 months after the previous assessement).

**Description:** From 16 to 64. Higher scores show more concern of falling.

**Measure:** Falls Efficacy Scale-International (FES-I)

**Time Frame:** Assessed after 3 months from the previous assessement.

**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).

**Measure:** European Quality of Life-5 Dimensions (EuroQol-5D)

**Time Frame:** Assessed before the first intervention (baseline).

**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).

**Measure:** European Quality of Life-5 Dimensions (EuroQol-5D)

**Time Frame:** Assessed after the first intervention (3 months later).

**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).

**Measure:** European Quality of Life-5 Dimensions (EuroQol-5D)

**Time Frame:** Assessed after the second intervention (3 months after the previous assessement).

**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).

**Measure:** European Quality of Life-5 Dimensions (EuroQol-5D)

**Time Frame:** Assessed after 3 months from the previous assessement.

**Description:** Assessed with and impedance scale.

**Measure:** Muscle mass

**Time Frame:** Assessed before the first intervention (baseline).

**Description:** Assessed with and impedance scale.

**Measure:** Muscle mass

**Time Frame:** Assessed after the first intervention (3 months later).

**Description:** Assessed with and impedance scale.

**Measure:** Muscle mass

**Time Frame:** Assessed after the second intervention (3 months after the previous assessement).

**Description:** Assessed with and impedance scale.

**Measure:** Muscle mass

**Time Frame:** Assessed after 3 months from the previous assessement.

### Eligibility Module

**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.

**Healthy Volunteers:** True

**Minimum Age:** 65 Years

**Sex:** ALL

**Standard Ages:**

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** bequelte@gmail.com

**Name:** Belén Quel Tejón

**Phone:** 675760137

**Role:** CONTACT

**Contact 2:**

**Email:** Jose.Maria.Blasco@uv.es

**Name:** José María Blasco Igual

**Phone:** 963983855

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Valencia

**Contacts:**

***Contact 1:***

- **Email:** Jose.Maria.Blasco@uv.es

- **Name:** José María Blasco Igual

- **Phone:** 963983855

- **Role:** CONTACT

**Country:** Spain

**Facility:** University of Valencia

**Status:** RECRUITING

**Zip:** 46010

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M1175

- Name: Frailty

- Relevance: HIGH

- As Found: Frailty

### Condition Browse Module - Meshes

- ID: D000073496

- Term: Frailty

### Misc Info Module

- Version Holder: 2024-05-24
