Exercise Therapy Clinical Trial
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
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.
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
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT03662438 -
HOPE (Home-based Oxygen [Portable] and Exercise) for Patients on Long Term Oxygen Therapy (LTOT)
|
N/A | |
| Not yet recruiting |
NCT05995197 -
The Effect of Action Observation Therapy on Balance in Patients With Cerebral Palsy
|
N/A | |
| Completed |
NCT04169646 -
Prevention and Intervention of Neck Pain in Swiss Office-Workers
|
N/A | |
| Not yet recruiting |
NCT05942417 -
Echoguided Percutaneous Neuromodulation in the Management of Chronic Ankle Instability in Physically Active Subjects.
|
N/A | |
| Completed |
NCT00808483 -
Walking Skill Training Program Effects in Patients With Total Hip Arthroplasty
|
N/A | |
| Recruiting |
NCT06131060 -
Progressive Eccentric VS Bodyweight Exercises on Agility, Power and Functional Performance in Hamstring Strain.
|
N/A | |
| Recruiting |
NCT04507789 -
Exercise Therapy During Radiotherapy
|
N/A | |
| Completed |
NCT05676528 -
Exercise Intervention for Employees of the University of Bern
|
N/A | |
| Completed |
NCT02975804 -
RCT on Interactive Computer Play on Trunk Control in CP
|
N/A | |
| Active, not recruiting |
NCT03540732 -
Feeding With Indirect Calorimetry and Cycling in the Elderly
|
N/A | |
| Completed |
NCT02615899 -
Effectiveness of Impairment Specific Exercises for Balance and Fall Risk in Community-Living Older Adults at Risk: A Randomized Controlled Trial
|
N/A | |
| Active, not recruiting |
NCT05770089 -
Videoconferencing Adapted Physical Activity in Anorexia Nervosa: a Pilot Study
|
N/A | |
| Recruiting |
NCT05823857 -
Effect of an Aquatic Exercise Program in Patients With Chronic Low Back Pain
|
N/A | |
| Completed |
NCT05771792 -
Comparison of Eccentric Training on Injury Prevention and Hamstring Strength in Football Players
|
N/A | |
| Recruiting |
NCT04121702 -
Outpatient Cardiac Tele-Rehabilitation in a Public Sports Center
|
N/A | |
| Not yet recruiting |
NCT06300281 -
Comparison of Neuromuscular and Aquatic Exercise Programs on Fall Risk and Physical Function in Geriatrics
|
N/A | |
| Completed |
NCT03709212 -
Cultural Influences on Physical Activity and Exercise Beliefs in Patients With Chronic Kidney Disease
|
||
| Not yet recruiting |
NCT06359444 -
Effect of High Intensity Exercise Rehabilitation on Liver Function and Insulin Sensitivity in Patients With MASLD
|
N/A | |
| Not yet recruiting |
NCT01861392 -
Analisys of Neuromuscular Response, Postural Balance and Quality of Life of Diabetics Type 2 After Sensory-motor Training: Blind Random Controled Clinical Trial
|
N/A | |
| Recruiting |
NCT06407089 -
Effectiveness of a Telerehabilitation Program Based on Specific Neck Exercises in Patients With Forward Head Posture.
|
N/A |