A Multi-component Intervention in Frail Community-dwelling Older People

NCT02918682 | Unknown

• 1 other identifier: 932.043
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study evaluates if a multi-component intervention, respecting the characteristics of frail older person and increasing intensity and challenge of exercises according to frail older person capacity/evolution will induce better functional results than a multi-component intervention specific to lower body. the volunteers will be randomized into experimental group and control group.

Conditions

Frail Elderly; Exercise Therapy; Physical Therapy Techniques

Outcome Measures

Primary Outcomes (4)

• strength muscle evaluation

  The Elbow flexors and extensors, trunk flexors and extensors, hip abductor and adductor, knee flexors and extensors and ankle dorsiflexors and plantarflexors muscle strength of the dominant limb will be evaluated by an isokinetic dynamometer

  baseline

• Balance

  Balance in semi-static stance was measured using the force platform. Data on 6 stances were collected for each subject: standing on a fixed platform with eyes open and closed; standing on an unstable platform with eyes open and closed; and in single-leg stance with eyes open on the right leg and on the left leg.

  baseline

• gait

  The gait parameters will be analyzed using the GAITRite Platinum 26' Portable Walkway System to evaluated spatial and temporal gait variables.

  baseline

• functional performance

  Timed Up and Go (TUG) test will be used.

  baseline

Secondary Outcomes (4)

• strength muscle evaluation

  change from baseline in 3 months

• Balance

  change from baseline in 3 months

• gait

  change from baseline in 3 months

• functional performance

  change from baseline in 3 months

Study Arms (2)

Exercise Group

EXPERIMENTAL

The multimodal intervention protocol is described separated by day (1 to 24) and by weeks (1 to 12). Each session was built to last between 50 and 60 minutes.

Other: Exercise - FIRST PHASE; Other: Exercise - SECOND PHASE; Other: Exercise - FOURTH PHASE; Other: Exercise - THIRD PHASE

Control Group

NO INTERVENTION

Participants from the control group will not perform any kind of physical exercise.

Interventions

Exercise - FIRST PHASE OTHER

the participants do not need to perform the first phase or can advance to the second phase if they have obtained the following results in the balance and functional tests: 1. Gait speed of 0.8 m/s and walking 30 meters without stopping; 2. Ability to perform the stand up and sit down test from the chair five times properly within less than 15 seconds; 3. Maintaining the FFEO stance for 30 seconds and the Tandem EO stance for more than 5 seconds; 4. Having sitting stability limits with eyes open; 5. In upright position, able to bend the trunk forward, standing parallel to a wall, between 16.5 - 32 cm but stable. For the muscle strength: being able to perform hip flexion with 50% of 1 repetition maximum (RM) for 8 repetitions; hip extension with 50% of 1RM for 8 repetitions; hip abduction without load but at least for 8 repetitions; knee extension with 50% of 1RM for 8 repetitions; knee flexion with 50 % of 1RM for 8 repetitions;

Exercise Group

Exercise - SECOND PHASE OTHER

the participants do not need to perform the second phase or can advance to the third phase if they have obtained the following results in the balance and functional tests: 1. Gait speed of 0.8-1 m/s and ability to walk 60 meters; 2. Ability to perform the stand up and sit down test from the chair five times properly within less than 15 seconds; 3. Maintaining the FFEO and FFEC stance for more than 5 seconds and the Tandem EO stance for 10-20 seconds; 4. Having sitting stability limits with eyes closed; 5. Being able to bend the trunk forward, standing parallel to a wall, between 20-32 cm ad being stable. For muscle strength: being able to perform hip flexion with 60% of 1 RM for 8 repetitions; hip extension with 60% of 1RM for 8 repetitions; hip abduction without load but between 8-12 repetitions; knee extension with 60% of 1RM for 8 repetitions; knee flexion with 60% of 1RM for 8 repetitions;

Exercise Group

Exercise - FOURTH PHASE OTHER

at the end of the exercise protocol, the participants who have reached the fourth phase must be able to achieve: 1. Gait speed of 0.8-1 m/s and able to walk 90 meters; 2. Stand up and sit down five times from the chair properly within less than 15 seconds; 3. TUG performance less than 14 seconds; 4. Maintenance of 30 seconds in FFEO and FFEC stance, maintenance of 30 seconds in Tandem EO and Tandem EC stance, maintenance of the single-leg stance for more than 21 seconds; 5. Normal sitting stability limits with eyes closed; 6. Bending the trunk forward, standing parallel to a wall, more than 32 cm and being stable. For muscle strength: able to perform hip flexion with 70% of 1 RM for 6-10 repetitions; hip extension with 70% of 1RM for 6-10 repetitions; hip abduction with 40-60% of 1RM for 8-12 repetitions; knee extension with 70% of 1RM for 6-10 repetitions; knee flexion with 70% of 1RM for 6-10 repetitions.

Exercise Group

Exercise - THIRD PHASE OTHER

participants do not need to perform the third phase or can advance to the fourth phase if they have obtained: 1 Gait speed of 0.8-1 m/s and walk 90 meters; 2 perform the stand up and sit down five times from the chair properly within less than 15 seconds; 3 Performing the TUG test within less than 14 seconds; 4 Maintaining the FFEO and FFEC stance for 30 seconds, maintaining the Tandem EO and Tandem EC stance for 30 seconds and maintaining the single-leg stance for more than 20 seconds; 5 Having sitting stability limits with eyes closed; 6 In the upright position, to bend the trunk forward, standing parallel to a wall, more than 32 cm and being stable. For the muscle strength test, perform hip flexion with 60 % of 1 RM for 8-12 repetitions; hip extension with 60 % of 1RM for 8-12 repetitions; hip abduction without load or 5% of 1RM for hip abductor and between 8-12 repetitions; knee extension with 60 % of 1RM for 8-12 repetitions; knee flexion with 60 % of 1RM for 8-12 repetitions;

Exercise Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may not qualify if:

• previous lower extremities orthopedic surgery, a history of fractures within the past year, an inability to walk unaided, carriers of neurological diseases, diagnosed acute inflammatory disease that could interfere in the assessments and the program, tumor growth in the last five years and cognitive impairment based on the mini-mental state examination \[4\]. Moreover, will be excluded volunteers who are absent more than three consecutive training and / or more than 25% of the sessions, and / or present the course of the physical program changes or decompensation and / or disease injury.

Sponsors & Collaborators

• University of Sao Paulo: lead

Related Publications (25)

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  BACKGROUND

Related Links

• World Health Organization. Active ageing: a policy framework.

Study Officials

• Daniela CC de Abreu, Professor

  School of Medicine of RibeirãoPreto, University of São Paulo, FMRP-USP

  STUDY CHAIR

Central Study Contacts

Natalia C Rodrigues, PhD

CONTACT

+55 16 33154413; nataliacrod@yahoo.com.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: the participants do not need to perform the first phase or can advance to the second phase if they have obtained the following results in the balance and functional tests: 1. Gait speed of 0.8 m/s and walking 30 meters without stopping; 2. Ability to perform the stand up and sit down test from the chair five times properly within less than 15 seconds; 3. Maintaining the FFEO stance for 30 seconds and the Tandem EO stance for more than 5 seconds; 4. Having sitting stability limits with eyes open; 5. In upright position, able to bend the trunk forward, standing parallel to a wall, between 16.5 - 32 cm but stable. For the muscle strength: being able to perform hip flexion with 50% of 1 repetition maximum (RM) for 8 repetitions; hip extension with 50% of 1RM for 8 repetitions; hip abduction without load but at least for 8 repetitions; knee extension with 50% of 1RM for 8 repetitions; knee flexion with 50 % of 1RM for 8 repetitions;

Study Record Dates

• First Submitted: September 26, 2016
• First Posted: September 29, 2016
• Study Start: December 1, 2019
• Primary Completion: December 1, 2020
• Study Completion: June 1, 2022
• Last Updated: April 23, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will share