Clinical trial NCT02918682: A Multi-component Intervention in Frail Community-dwelling Older People
Official title: The Effects of a Multi-component Intervention on the Functional Capacity, Upper and Lower-body Muscle Strength, Balance and Gait in Frail Community-dwelling Older People: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Frail Elderly
Exercise Therapy
Physical Therapy Techniques
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2016-09-29
Enrollment: 30
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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;
Primary purpose: TREATMENT

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.

Detailed description: The interventions are separated by day (1 to 24) and by weeks (1 to 12). Each session was built to last between 50 and 60 minutes, beginning with a warming up. In the table are described the exercise as well as the support necessary to perform the exercise safely and necessary equipment (accessories). In cases where a minimum load is required the same are also described in the multimodal intervention protocol (load).

In relation to strength training in the multimodal intervention protocol is described how the progression of intensity will be held. Additional to the load progression suggested, the 1 maximal repetition test will be applied every 4 weeks for adjustment of the loads according to strength gain from each volunteer.

The suggested protocol is based on balance exercises and strength but, in a careful manner, were included functional and mobilization exercises to ensure greater diversity.

Multimodal intervention protocol:

1. a week

   Day 1. Balance Training 1.1 P: Seated on the chair; E: Position Adjustments, (Anterior-posterior, medial-lateral); S: Yes (parallel bar) 1.2 P: Seated on the chair; E: Hip mobilization, Anterior- posterior; S: Yes(parallel bar)

   Strength Training 1.1 P: Dorsal Decubitus; E: Hip Flexion 1.2 P:Lateral Decubitus; E: Hip Abduction 1.3 P:Seated on the chair; E: Knee Extension 1.4 P:Seated on the chair; E: Dorsiflexion/ Plantar Flexion 1.5 P:Seated on the chair; E: Trunk stabilization; A: Stick
2. sets, 12 repetitions, 50% RM

P: Position ; E: Exercise ; S: Support; A: Accessory; L: Load ; RM: Repetition Maximum

Day 2. Balance Training 2.1 P: Seated on the chair; E: Position Adjustments (Anterior-posterior, medial-lateral);S: Yes(parallel bar) 2.2 P: Seated on the chair; E: Hip mobilization Anterior- posterior; S: Yes(parallel bar)

Strength Training 2.1 P: Ventral Decubitus; E: Hip Extension (hollowing) 2.2 P:Lateral Decubitus; E: Hip Aduction 2.3 P: Standing; E: Semi-squat; A: peanut ball 2.4 P: Standing; E: Knee Flexion; S: Yes (parallel bar or back rest)

2 sets, 12 repetitions, 50% RM

P: Position ; E: Exercise ; S: Support; A: Accessory; L: Load ; RM: Repetition Maximum

2a week

Day 3. Balance Training 3.1 P:Seated on the chair; E: Trunk mobilization Latero-lateral; S: Yes (parallel bar) 3.2 P:Seated on the chair; E: Trunk mobilization Anterior-posterior; S: Yes(parallel bar) 3.3 P: Standing; E:Romberg- feet together, semi-tandem, tandem; S: Yes(parallel bar) Strength Training 3.1 P: Dorsal Decubitus; E: Hip Flexion 3.2 P:Lateral Decubitus; E: Hip Abduction 3.3 P:Seated on the chair; E: Knee Extension 3.4 P:Seated on the chair; E: Dorsiflexion/ Plantar Flexion 3.5 P:Seated on the chair; E: Trunk stabilization; A: Stick 2 sets, 12 repetitions, 50% RM

P: Position ; E: Exercise ; S: Support; A: Accessory; L: Load ; RM: Repetition Maximum

Day 4. Balance Training 4.1 P:Seated on the chair; E: Trunk mobilization Latero-lateral; S: Yes (parallel bar) 4.2 P:Seated on the chair; E: Trunk mobilization Anterior-posterior; S: No 4.3 P: Standing; E:Romberg- feet together, semi-tandem, tandem; S: Yes(parallel bar) Strength Training 4.1 P:Ventral Decubitus; E: Hip Extension (hollowing) 4.2 P:Lateral Decubitus; E: Hip Aduction 4.3 P: Standing; E: Semi-squat; A: peanut ball 4.4 P: Standing; E: Knee Flexion; S: Yes (parallel bar or back rest )

2 sets, 12 repetitions, 50% RM

P: Position ; E: Exercise ; S: Support; A: Accessory; L: Load ; RM: Repetition Maximum

3a week

Day 5. Balance Training 5.1 P: Standing; E: Side step walking; S: Yes (parallel bar) 5.2 P: Standing; E: Sitting to standing; S: Yes (parallel bar or) back rest 5.3 P: Standing; E:Romberg- feet together, semi-tandem, tandem; S: No 5.4 P: Table pose (Time: 60s )

Strength Training 5.1 P: Dorsal Decubitus; E: Hip Flexion 5.2 P:Lateral Decubitus; E: Hip Abduction 5.3 P:Seated in the chair; E: Knee Extension 5.4 P:Seated on the chair; E: Dorsiflexion/ Plantar Flexion

2 sets, 12 repetitions, 50% RM

P: Position ; E: Exercise ; S: Support; A: Accessory; L: Load ; RM: Repetition Maximum

Day 6. Balance Training 6.1 P: Standing; E:Side step walking; S: Yes (parallel bar) 6.2 P: Standing; E: Sitting to standing; S: Yes (parallel bar or back rest) 6.3 P: Standing; E:Romberg- feet together, semi-tandem, tandem; S: No 6.4 P: Table pose(Time: 60s )

Strength Training 6.1 P:Ventral Decubitus; E: Hip Extension (hollowing + one leg up) 6.2 P:Lateral Decubitus; E: Hip Aduction 6.3 P: Standing; E: Semi-squat; A: peanut ball 6.4 P: Standing; E: Knee Flexion; S: Yes(parallel bar or back rest)

2 sets, 12 repetitions, 50% RM

P: Position ; E: Exercise ; S: Support; A: Accessory; L: Load ; RM: Repetition Maximum

4a week

Day 7. Balance Training 7.1 P: Standing; E: Walk to Front and Back; S: Yes (parallel bar) 7.2 P: Standing; E: Side step walking; S: No 7.3 P: Seated on the chair; E: Sit to standing; S: Standing: No; Sitting: Yes (parallel bar or back rest) 7.4 P: Table pose(Time: 60s ) 7.5 P: Standing; E:Romberg- feet together, semi-tandem, tandem; S: No

Strength Training 7.1 P: Dorsal Decubitus; E: Hip Flexion 7.2 P:Lateral Decubitus; E: Hip Abduction 7.3 P:Seated in the chair; E: Knee Extension 7.4 P:Standing; E: Dorsiflexion/ Plantar Flexion; S:Yes(parallel bar or back rest )

2 sets, 12 repetitions, 50% RM

P: Position ; E: Exercise ; S: Support; A: Accessory; L: Load ; RM: Repetition Maximum

Day 8. Balance Training 8.1 P: Standing; E: Walk to Front and Back; S: Yes (parallel bar) 8.2 P: Standing; E: Side step walking; S: No 8.3 P: Seated on the chair; E: Sit to standing; S: Standing: No; Sitting: Yes(parallel bar or back rest) 8.4 P: Table pose(Time: 60s ) 8.5 P: Standing; E:Romberg- feet together, semi-tandem, tandem; S: No

Strength Training 8.1 P:Ventral Decubitus; E: Hip Extension (hollowing + one leg up) 8.2 P:Lateral Decubitus; E: Hip Aduction 8.3 P: Standing; E: Semi-squat; L: 0.5 Kg 8.4 P: Standing; E: Knee Flexion; S: No

2 sets, 12 repetitions, 50% RM

P: Position ; E: Exercise ; S: Support; A: Accessory; L: Load ; RM: Repetition Maximum

5a week

Day 9. Balance Training 9.1 P: Seated on the chair; E: Sitting to standing; S: No 9.2 P: Standing; E: One leg stance; S: Yes(parallel bar) 9.3 P: Standing; E: Walk to Front and Back; S: No 9.4 P: Standing; E: Tandem position; S: No + ocular fixation

Strength Training 9.1 P: Dorsal Decubitus; E:Hip Flexion 9.2 P:Lateral Decubitus; E: Hip Abduction 9.3 P:Seated on the chair; E: Knee Extension 9.4 P:Standing; E: Dorsiflexion/ Plantar Flexion; S:Yes (parallel bar or back rest)

3 sets, 10 repetitions, 55-65% RM

P: Position ; E: Exercise ; S: Support; A: Accessory; L: Load ; RM: Repetition Maximum

Day 10. Balance Training 10.1 P: Seated on the chair; E: Sitting to standing; S: No 10.2 P: Standing; E: One leg stance; S: Yes (parallel bar) 10.3 P: Standing; E: Walk to Front and Back; S: No 10.4 P: Standing; E: Tandem position; S: No + ocular fixation

Strength Training 10.1 P: Ventral Decubitus; E: Hip Extension (Table position) 10.2 P:Lateral Decubitus; E: Hip Aduction 10.3 P:Standing; E: Semi-squat; S:No; L:1 Kg 10.4 P: Standing; E: Knee Flexion; S: Yes(parallel bar or back rest)

3 sets, 10 repetitions, 55-65% RM

P: Position ; E: Exercise ; S: Support; A: Accessory; L: Load ; RM: Repetition Maximum

6a week

Day 11. Balance Training 11.1 P: Standing; E:Crossed Gait (Braiding); S:Yes (parallel bar) 11.2 P: Standing; E: Turn 90º or 180º; S:Yes(parallel bar) 11.3 P: Standing; Reactive Balance (Ankle, Hip, Step); S:Yes(parallel bar) 11.4 P:Standing; E:Romberg- feet together; S: No+ eyes closed 11.5 P: Standing; E: One leg stance; S: No

Strength Training 11.1 P: Dorsal Decubitus; E:Hip Flexion 11.2 P:Lateral Decubitus; E: Hip Abduction 11.3 P:Seated on the chair; E: Knee Extension 11.4 P:Standing; E: Dorsiflexion/ Plantar Flexion; S:Yes(parallel bar or back rest)

3 sets, 10 repetitions, 55-65% RM

P: Position ; E: Exercise ; S: Support; A: Accessory; L: Load ; RM: Repetition Maximum

Day 12. Balance Training 12.1 P: Standing; E:Crossed Gait (Braiding); S:Yes (parallel bar) 12.2 P: Standing; E: Turn 90º or 180º; S:Yes(parallel bar) 12.3 P: Standing; Reactive Balance (Ankle, Hip, Step); S:Yes(parallel bar) 12.4 P:Standing; E:Romberg- feet together; S: No+ eyes closed 12.5 P: Standing; E: One leg stance; S: No

Strength Training 12.1 P: Ventral Decubitus; E: Hip Extension (Table position) 12.2 P:Lateral Decubitus; E: Hip Aduction 12.3 P:Standing; E: Semi-squat; S:No; L:1 Kg 12.4 P: Standing; E: Knee Flexion; S: Yes(parallel bar or back rest) 3 sets, 10 repetitions, 55-65% RM

P: Position ; E: Exercise ; S: Support; A: Accessory; L: Load ; RM: Repetition Maximum

7a week

Day 13. Balance Training 13.1 P: Standing; E:Walk with Hip flexion 90o like soldier); S: Yes, (parallel bar) 13.2 P: Standing; E: Turn 180º ou 360º; S:Yes(parallel bar) 13.3 P: Standing; E:Walk (6 meters) increasing step length; S: No 13.4 P: Standing; E:Tandem Posture; S: No 13.5 P: Standing; E: One leg stance; S: No + eyes closed

Strength Training 13.1 P: Dorsal Decubitus; E: Hip Flexion 13.2 P:Lateral Decubitus; E: Hip Abduction 13.3 P:Seated on the chair; E: Knee Extension 13.4 P:Standing; E: Dorsiflexion/ Plantar Flexion; S:Yes(parallel bar or back rest)

3 sets, 10 repetitions, 55-65% RM

P: Position ; E: Exercise ; S: Support; A: Accessory; L: Load ; RM: Repetition Maximum

Day 14. Balance Training 14.1 P: Standing; E:Walk with Hip flexion 90o like soldier); S:Yes(parallel bar) 14.2 P: Standing; E: Turn 180º ou 360º; S:Ye(parallel bar)s 14.3 P: Standing; E:Walk (6 meters) increasing step length; S: No 14.4 P: Standing; E:Tandem Posture; S: No 14.5 P: Standing; E: One leg stance; S: No + eyes closed

Strength Training 14.1 P: Ventral Decubitus; E: Hip Extension (Table position) 14.2 P:Lateral Decubitus; E: Hip Aduction 14.3 P:Standing; E: Semi-squat; S:No; L:1 Kg 14.4 P: Standing; E: Knee Flexion; S: Yes(parallel bar or back rest)

3 sets, 10 repetitions, 55-65% RM

P: Position ; E: Exercise ; S: Support; A: Accessory; L: Load ; RM: Repetition Maximum

8a week

Day 15. Balance Training 15.1 P: Standing; E:Walk with Hip flexion 90o like soldier); S:No 15.2 P: Standing; E: Tandem Gait; S: Yes(parallel bar) 15.3 P: Standing; E: Step up and down; S: No 15.4 P: Seated on the chair; E:TUG habitual walk speed; S: No 15.5 P:Standing; E:Romberg- feet together; S: No+ ball reach

Strength Training 15.1 P: Dorsal Decubitus; E: Hip Flexion 15.2 P:Lateral Decubitus; E: Hip Abduction 15.3 P:Seated on the chair; E: Knee Extension 15.4 P:Standing; E: Dorsiflexion/ Plantar Flexion; S:Yes(parallel bar or back rest)

3 sets, 10 repetitions, 55-65% RM

P: Position ; E: Exercise ; S: Support; A: Accessory; L: Load ; RM: Repetition Maximum

Day 16. Balance Training 16.1 P: Standing; E:Walk with Hip flexion 90o like soldier); S:No 16.2 P: Standing; E: Tandem Gait; S: Yes(parallel bar) 16.3 P: Standing; E: Step up and down; S: No 16.4 P: Seated on the chair; E:TUG habitual walk speed; S: No 16.5 P:Standing; E:Romberg- feet together; S: No+ ball reach

Strength Training 16.1 P: Ventral Decubitus; E: Hip Extension (Table position + raise one arm) 16.2 P:Lateral Decubitus; E: Hip Aduction 16.3 P:Standing; E: Squat; S:No 16.4 P: Standing; E: Knee Flexion; S: Yes(parallel bar or back rest) 3 sets, 10 repetitions, 55-65% RM

P: Position ; E: Exercise ; S: Support; A: Accessory; L: Load ; RM: Repetition Maximum

9a week

Day 17. Balance Training 17.1 P:Standing; E:Romberg- feet together; S: No+ ball reach 17.2 P: Standing; E: Step up and down; S: No 17.3 P: Seated on the chair; E:TUG habitual walk speed; S: No + Dual task (cognitive) 17.4 P: Standing; E:Walk (6 meters) increasing speed; S: No

Strength Training 17.1 P: Dorsal Decubitus; E:Hip Flexion 17.2 P:Lateral Decubitus; E: Hip Abduction 17.3 P:Seated on the chair; E: knee extension 17.4 P:Standing; E: Dorsiflexion/ Plantar Flexion; S:Yes (parallel bar or back rest) 3 sets, 8 repetitions, 65-75% RM

P: Position ; E: Exercise ; S: Support; A: Accessory; L: Load ; RM: Repetition Maximum

Day 18. Balance Training 18.1 P:Standing; E:Romberg- feet together; S: No+ ball reach 18.2 P: Standing; E: Step up and down; S: No 18.3 P: Seated on the chair; E:TUG habitual walk speed; S: No + Dual task (cognitive) 18.4 P: Standing; E:Walk (6 meters) increasing step length; S: No

Strength Training 18.1 P: Ventral Decubitus; E: Hip Extension (Table position + raise arm and leg) 18.2 P:Lateral Decubitus; E: Hip Aduction 18.3 P:Standing; E: Split Squat; S:No; L:0.5 Kg 18.4 P: Standing; E: Knee Flexion; S: Yes (parallel bar or back rest)

3 sets, 8 repetitions, 65-75% RM

P: Position ; E: Exercise ; S: Support; A: Accessory; L: Load ; RM: Repetition Maximum

10a week

Day 19. Balance Training

19.1 P:Standing; E:Romberg- feet together; S: No+ Reach tasks 19.2 P: Standing E:Side step walking; S: No+ ball reach 19.3 P:Standing; E:Romberg- feet together; S: No+ unstable surface+ eyes opened and closed 19.4 P: Standing; E:Walk (6 meters) increasing step length; S: No Strength Training 19.1 P: Dorsal Decubitus; E:Hip Flexion 19.2 P:Lateral Decubitus; E: Hip Abduction 19.3 P:Seated on the chair; E: Knee Extension 19.4 P:Standing; E: Dorsiflexion/ Plantar Flexion; S:Yes (parallel bar or back res)

3 sets, 8 repetitions, 65-75% RM

P: Position ; E: Exercise ; S: Support; A: Accessory; L: Load ; RM: Repetition Maximum

Day 20. Balance Training 20.1 P:Standing; E:Romberg- feet together; S: No+ Reach tasks 20.2 P: Standing; E:Side step walking; S: No+ ball reach 20.3 P: Standing; E: One leg stance; S: No + unstable surface 20.4 P: Standing; E:Walk (6 meters) with scapular dissociation and cervical rotation; S: No

Strength Training 20.1 P: Ventral Decubitus; E: Hip Extension (Table position + raise arm and leg) 20.2 P:Lateral Decubitus; E: Hip Aduction 20.3 P:Standing; E: Split Squat; S:No; L:0.5 Kg 20.4 P: Standing; E: Knee Flexion; S: Yes(parallel bar or back rest)

3 sets, 8 repetitions, 65-75% RM

P: Position ; E: Exercise ; S: Support; A: Accessory; L: Load ; RM: Repetition Maximum

11a week

Day 21. Balance Training

Circuit Training:

1. Stepping over barriers (Rolls, Steps)
2. Gait Training (increasing step length, changing speed, with scapular dissociation and cervical rotation)
3. Gait with motor tasks (Ball reach )
4. Balance Boards

Strength Training 21.1 P: Dorsal Decubitus; E:Hip Flexion 21.2 P:Lateral Decubitus; E: Hip Abduction 21.3 P:Seated on the chair; E: Knee Extension; S:Yes(parallel bar or back rest) 21.4 P:Standing; E: Dorsiflexion/ Plantar Flexion; S:Yes(parallel bar or back rest)

3 sets, 8 repetitions, 65-75% RM

P: Position ; E: Exercise ; S: Support; A: Accessory; L: Load ; RM: Repetition Maximum

Day 22. Balance Training

Circuit Training:

1. Stepping over barriers (Rolls, Steps)
2. Gait Training (increasing step length, changing speed, with scapular dissociation and cervical rotation)
3. Gait with motor tasks (Ball reach)
4. Balance Boards

Strength Training

22.1 P: Ventral Decubitus; E: Hip Extension (Table position + raise arm and leg); L: 0.5 Kg 22.2 P:Lateral Decubitus 22.3 P:Standing; E: Split Squat; S:No; E: Hip Aduction; L:1.0 Kg 22.4 P: Standing; E: Knee Flexion; S: Yes(parallel bar or back rest)

3 sets, 8 repetitions, 65-75% RM

P: Position ; E: Exercise ; S: Support; A: Accessory; L: Load ; RM: Repetition Maximum

12a week

Day 23. Balance Training

Circuit Training:

1.1 Stepping over barriers (Rolls, Steps) 2.Gait Training (increasing step length, changing speed, with scapular dissociation and cervical rotation) 3.Gait with cognitive tasks 4.Balance Boards

Strength Training

23.1 P: Dorsal Decubitus; E:Hip Flexion 23.2 P:Lateral Decubitus; E: Hip Abduction 23.3 P:Seated on the chair; E: Knee Extension 23.4 P:Standing; E: Dorsiflexion/ Plantar Flexion; S:Yes (parallel bar or back rest)

3 sets, 8 repetitions, 65-75% RM

P: Position ; E: Exercise ; S: Support; A: Accessory; L: Load ; RM: Repetition Maximum

Day 24. Balance Training

Circuit Training:

1.1 Stepping over barriers (Rolls, Steps) 2.Gait Training (increasing step length, changing speed, with scapular dissociation and cervical rotation) 3.Gait with cognitive tasks 4.Balance Boards

Strength Training 24.1 P: Ventral Decubitus; E: Hip Extension (Table position + raise arm and leg); L: 0.5 Kg 24.2 P:Lateral Decubitus; E: Hip Aduction 24.3 P:Standing; E: Split Squat; S:No; L:0.5 Kg 24.4 P: Standing; E: Knee Flexion; S: Yes(parallel bar or back rest)

3 sets, 8 repetitions, 65-75% RM

P: Position ; E: Exercise ; S: Support; A: Accessory; L: Load ; RM: Repetition Maximum

Eligibility criteria: Inclusion Criteria:

* volunteers above the age of 65 who are community residents and classified as frail according to the criteria established by Fried et al. will be selected for inclusion in the study

Exclusion Criteria:

* 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.

Primary outcomes:
measure: strength muscle evaluation
timeFrame: baseline
measure: Balance
timeFrame: baseline
measure: gait
timeFrame: baseline
measure: functional performance
timeFrame: baseline
Secondary outcomes:
measure: strength muscle evaluation
timeFrame: change from baseline in 3 months
measure: Balance
timeFrame: change from baseline in 3 months
measure: gait
timeFrame: change from baseline in 3 months
measure: functional performance
timeFrame: change from baseline in 3 months
Other outcomes:
Locations:
Study officials:
affiliation: School of Medicine of RibeirãoPreto, University of São Paulo, FMRP-USP
name: Daniela CC de Abreu, Professor
role: STUDY_CHAIR
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