Trial Outcomes & Findings for Intervention to Enhance Lateral Balance Function and Prevent Falls in Aging (NCT NCT01370174)
NCT ID: NCT01370174
Last Updated: 2021-10-05
Results Overview
Hip abductor torque at baseline and 3 months
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
102 participants
Primary outcome timeframe
At baseline and post-test at 3 months
Results posted on
2021-10-05
Participant Flow
Participant milestones
| Measure |
Induced Step Training (IST)
The IST group will receive waist-pulls in both the left and right lateral directions by a motorized pulling system to produce stepping.
Physical Training Interventions: Subjects will be assigned to one of four training groups. Training will occur three times weekly for twelve consecutive weeks. The IST group will receive waist-pulls by a motorized machine to produce stepping. Subjects in the HST group will perform muscle resistance exercises. Subjects in the combined IST and HST will receive both IST and HST interventions. Participants in the SFR group will perform flexibility and relaxation exercises.
|
Hip Strength Training (HST)
The HST group will have muscle strength training, to include hip abduction (AB) and adduction (AD) resistance exercises.
Physical Training Interventions: Subjects will be assigned to one of four training groups. Training will occur three times weekly for twelve consecutive weeks. The IST group will receive waist-pulls by a motorized machine to produce stepping. Subjects in the HST group will perform muscle resistance exercises. Subjects in the combined IST and HST will receive both IST and HST interventions. Participants in the SFR group will perform flexibility and relaxation exercises.
|
Combined Induced Step and Hip Strength Training
This training group consists of combined induced step training (IST) and hip AB-AD strength training (HST).
Physical Training Interventions: Subjects will be assigned to one of four training groups. Training will occur three times weekly for twelve consecutive weeks. The IST group will receive waist-pulls by a motorized machine to produce stepping. Subjects in the HST group will perform muscle resistance exercises. Subjects in the combined IST and HST will receive both IST and HST interventions. Participants in the SFR group will perform flexibility and relaxation exercises.
|
Standard Flexibility and Relaxation (SFR)
The SFR group will perform a flexibility and relaxation program involving minimal-intensity exercises.
Physical Training Interventions: Subjects will be assigned to one of four training groups. Training will occur three times weekly for twelve consecutive weeks. The IST group will receive waist-pulls by a motorized machine to produce stepping. Subjects in the HST group will perform muscle resistance exercises. Subjects in the combined IST and HST will receive both IST and HST interventions. Participants in the SFR group will perform flexibility and relaxation exercises.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
25
|
26
|
25
|
26
|
|
Overall Study
COMPLETED
|
18
|
15
|
13
|
17
|
|
Overall Study
NOT COMPLETED
|
7
|
11
|
12
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Intervention to Enhance Lateral Balance Function and Prevent Falls in Aging
Baseline characteristics by cohort
| Measure |
Induced Step Training (IST)
n=25 Participants
The IST group will receive waist-pulls in both the left and right lateral directions by a motorized pulling system to produce stepping.
Physical Training Interventions: Subjects will be assigned to one of four training groups. Training will occur three times weekly for twelve consecutive weeks. The IST group will receive waist-pulls by a motorized machine to produce stepping. Subjects in the HST group will perform muscle resistance exercises. Subjects in the combined IST and HST will receive both IST and HST interventions. Participants in the SFR group will perform flexibility and relaxation exercises.
|
Hip Strength Training (HST)
n=26 Participants
The HST group will have muscle strength training, to include hip abduction (AB) and adduction (AD) resistance exercises.
Physical Training Interventions: Subjects will be assigned to one of four training groups. Training will occur three times weekly for twelve consecutive weeks. The IST group will receive waist-pulls by a motorized machine to produce stepping. Subjects in the HST group will perform muscle resistance exercises. Subjects in the combined IST and HST will receive both IST and HST interventions. Participants in the SFR group will perform flexibility and relaxation exercises.
|
Combined Induced Step and Hip Strength Training
n=25 Participants
This training group consists of combined induced step training (IST) and hip AB-AD strength training (HST).
Physical Training Interventions: Subjects will be assigned to one of four training groups. Training will occur three times weekly for twelve consecutive weeks. The IST group will receive waist-pulls by a motorized machine to produce stepping. Subjects in the HST group will perform muscle resistance exercises. Subjects in the combined IST and HST will receive both IST and HST interventions. Participants in the SFR group will perform flexibility and relaxation exercises.
|
Standard Flexibility and Relaxation (SFR)
n=26 Participants
The SFR group will perform a flexibility and relaxation program involving minimal-intensity exercises.
Physical Training Interventions: Subjects will be assigned to one of four training groups. Training will occur three times weekly for twelve consecutive weeks. The IST group will receive waist-pulls by a motorized machine to produce stepping. Subjects in the HST group will perform muscle resistance exercises. Subjects in the combined IST and HST will receive both IST and HST interventions. Participants in the SFR group will perform flexibility and relaxation exercises.
|
Total
n=102 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
25 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
26 Participants
n=7 Participants
|
102 Participants
n=31 Participants
|
|
Age, Continuous
|
73.8 years
STANDARD_DEVIATION 6.3 • n=99 Participants
|
71.9 years
STANDARD_DEVIATION 6.8 • n=107 Participants
|
73.3 years
STANDARD_DEVIATION 5.9 • n=206 Participants
|
71.2 years
STANDARD_DEVIATION 4.2 • n=7 Participants
|
72.8 years
STANDARD_DEVIATION 5.8 • n=31 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
18 Participants
n=7 Participants
|
61 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
41 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=99 Participants
|
26 participants
n=107 Participants
|
25 participants
n=206 Participants
|
26 participants
n=7 Participants
|
102 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: At baseline and post-test at 3 monthsHip abductor torque at baseline and 3 months
Outcome measures
| Measure |
Induced Step Training (IST)
n=25 Participants
The IST group will receive waist-pulls in both the left and right lateral directions by a motorized pulling system to produce stepping.
Physical Training Interventions: Subjects will be assigned to one of four training groups. Training will occur three times weekly for twelve consecutive weeks. The IST group will receive waist-pulls by a motorized machine to produce stepping. Subjects in the HST group will perform muscle resistance exercises. Subjects in the combined IST and HST will receive both IST and HST interventions. Participants in the SFR group will perform flexibility and relaxation exercises.
|
Hip Strength Training (HST)
n=26 Participants
The HST group will have muscle strength training, to include hip abduction (AB) and adduction (AD) resistance exercises.
Physical Training Interventions: Subjects will be assigned to one of four training groups. Training will occur three times weekly for twelve consecutive weeks. The IST group will receive waist-pulls by a motorized machine to produce stepping. Subjects in the HST group will perform muscle resistance exercises. Subjects in the combined IST and HST will receive both IST and HST interventions. Participants in the SFR group will perform flexibility and relaxation exercises.
|
Combined Induced Step and Hip Strength Training
n=25 Participants
This training group consists of combined induced step training (IST) and hip AB-AD strength training (HST).
Physical Training Interventions: Subjects will be assigned to one of four training groups. Training will occur three times weekly for twelve consecutive weeks. The IST group will receive waist-pulls by a motorized machine to produce stepping. Subjects in the HST group will perform muscle resistance exercises. Subjects in the combined IST and HST will receive both IST and HST interventions. Participants in the SFR group will perform flexibility and relaxation exercises.
|
Standard Flexibility and Relaxation (SFR)
n=26 Participants
The SFR group will perform a flexibility and relaxation program involving minimal-intensity exercises.
Physical Training Interventions: Subjects will be assigned to one of four training groups. Training will occur three times weekly for twelve consecutive weeks. The IST group will receive waist-pulls by a motorized machine to produce stepping. Subjects in the HST group will perform muscle resistance exercises. Subjects in the combined IST and HST will receive both IST and HST interventions. Participants in the SFR group will perform flexibility and relaxation exercises.
|
|---|---|---|---|---|
|
Hip Abductor Torque
Baseline (Hip Strength Torque/Power)
|
0.49 Nm/kg-m
Standard Error 0.04
|
0.49 Nm/kg-m
Standard Error 0.02
|
0.59 Nm/kg-m
Standard Error 0.04
|
0.0523 Nm/kg-m
Standard Error 0.03
|
|
Hip Abductor Torque
Post-Test (Hip Strength Torque/Power)
|
0.52 Nm/kg-m
Standard Error 0.03
|
0.61 Nm/kg-m
Standard Error 0.03
|
0.62 Nm/kg-m
Standard Error 0.05
|
0.55 Nm/kg-m
Standard Error 0.03
|
PRIMARY outcome
Timeframe: At baseline and post-test at 3 monthsThe number of balance recovery steps at balance tolerance threshold at baseline and 3 months
Outcome measures
| Measure |
Induced Step Training (IST)
n=25 Participants
The IST group will receive waist-pulls in both the left and right lateral directions by a motorized pulling system to produce stepping.
Physical Training Interventions: Subjects will be assigned to one of four training groups. Training will occur three times weekly for twelve consecutive weeks. The IST group will receive waist-pulls by a motorized machine to produce stepping. Subjects in the HST group will perform muscle resistance exercises. Subjects in the combined IST and HST will receive both IST and HST interventions. Participants in the SFR group will perform flexibility and relaxation exercises.
|
Hip Strength Training (HST)
n=26 Participants
The HST group will have muscle strength training, to include hip abduction (AB) and adduction (AD) resistance exercises.
Physical Training Interventions: Subjects will be assigned to one of four training groups. Training will occur three times weekly for twelve consecutive weeks. The IST group will receive waist-pulls by a motorized machine to produce stepping. Subjects in the HST group will perform muscle resistance exercises. Subjects in the combined IST and HST will receive both IST and HST interventions. Participants in the SFR group will perform flexibility and relaxation exercises.
|
Combined Induced Step and Hip Strength Training
n=25 Participants
This training group consists of combined induced step training (IST) and hip AB-AD strength training (HST).
Physical Training Interventions: Subjects will be assigned to one of four training groups. Training will occur three times weekly for twelve consecutive weeks. The IST group will receive waist-pulls by a motorized machine to produce stepping. Subjects in the HST group will perform muscle resistance exercises. Subjects in the combined IST and HST will receive both IST and HST interventions. Participants in the SFR group will perform flexibility and relaxation exercises.
|
Standard Flexibility and Relaxation (SFR)
n=26 Participants
The SFR group will perform a flexibility and relaxation program involving minimal-intensity exercises.
Physical Training Interventions: Subjects will be assigned to one of four training groups. Training will occur three times weekly for twelve consecutive weeks. The IST group will receive waist-pulls by a motorized machine to produce stepping. Subjects in the HST group will perform muscle resistance exercises. Subjects in the combined IST and HST will receive both IST and HST interventions. Participants in the SFR group will perform flexibility and relaxation exercises.
|
|---|---|---|---|---|
|
Step Count
Baseline Balance Recovery Steps
|
1.63 steps
Standard Error .057
|
1.55 steps
Standard Error .042
|
1.67 steps
Standard Error .073
|
1.78 steps
Standard Error .065
|
|
Step Count
Post-Test Balance Recovery Steps
|
1.14 steps
Standard Error .080
|
1.24 steps
Standard Error .12
|
0.97 steps
Standard Error .067
|
1.24 steps
Standard Error .099
|
SECONDARY outcome
Timeframe: Individual subject at 12 months post trainingPopulation: Not all study participants completed the falls following. The falls follow up was removed late in the trial.
Analysis of fall history between falls in the year prior to enrollment and 12 months after training finished.
Outcome measures
| Measure |
Induced Step Training (IST)
n=18 Participants
The IST group will receive waist-pulls in both the left and right lateral directions by a motorized pulling system to produce stepping.
Physical Training Interventions: Subjects will be assigned to one of four training groups. Training will occur three times weekly for twelve consecutive weeks. The IST group will receive waist-pulls by a motorized machine to produce stepping. Subjects in the HST group will perform muscle resistance exercises. Subjects in the combined IST and HST will receive both IST and HST interventions. Participants in the SFR group will perform flexibility and relaxation exercises.
|
Hip Strength Training (HST)
n=15 Participants
The HST group will have muscle strength training, to include hip abduction (AB) and adduction (AD) resistance exercises.
Physical Training Interventions: Subjects will be assigned to one of four training groups. Training will occur three times weekly for twelve consecutive weeks. The IST group will receive waist-pulls by a motorized machine to produce stepping. Subjects in the HST group will perform muscle resistance exercises. Subjects in the combined IST and HST will receive both IST and HST interventions. Participants in the SFR group will perform flexibility and relaxation exercises.
|
Combined Induced Step and Hip Strength Training
n=13 Participants
This training group consists of combined induced step training (IST) and hip AB-AD strength training (HST).
Physical Training Interventions: Subjects will be assigned to one of four training groups. Training will occur three times weekly for twelve consecutive weeks. The IST group will receive waist-pulls by a motorized machine to produce stepping. Subjects in the HST group will perform muscle resistance exercises. Subjects in the combined IST and HST will receive both IST and HST interventions. Participants in the SFR group will perform flexibility and relaxation exercises.
|
Standard Flexibility and Relaxation (SFR)
n=17 Participants
The SFR group will perform a flexibility and relaxation program involving minimal-intensity exercises.
Physical Training Interventions: Subjects will be assigned to one of four training groups. Training will occur three times weekly for twelve consecutive weeks. The IST group will receive waist-pulls by a motorized machine to produce stepping. Subjects in the HST group will perform muscle resistance exercises. Subjects in the combined IST and HST will receive both IST and HST interventions. Participants in the SFR group will perform flexibility and relaxation exercises.
|
|---|---|---|---|---|
|
Falls
|
0.39 #falls/person/year
Interval 0.19 to 0.82
|
0.27 #falls/person/year
Interval 0.1 to 0.71
|
0.23 #falls/person/year
Interval 0.07 to 0.72
|
0.88 #falls/person/year
Interval 0.53 to 1.16
|
Adverse Events
Induced Step Training (IST)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Hip Strength Training (HST)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Combined Induced Step and Hip Strength Training
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Standard Flexibility and Relaxation (SFR)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Induced Step Training (IST)
n=25 participants at risk
The IST group will receive waist-pulls in both the left and right lateral directions by a motorized pulling system to produce stepping.
Physical Training Interventions: Subjects will be assigned to one of four training groups. Training will occur three times weekly for twelve consecutive weeks. The IST group will receive waist-pulls by a motorized machine to produce stepping. Subjects in the HST group will perform muscle resistance exercises. Subjects in the combined IST and HST will receive both IST and HST interventions. Participants in the SFR group will perform flexibility and relaxation exercises.
|
Hip Strength Training (HST)
n=26 participants at risk
The HST group will have muscle strength training, to include hip abduction (AB) and adduction (AD) resistance exercises.
Physical Training Interventions: Subjects will be assigned to one of four training groups. Training will occur three times weekly for twelve consecutive weeks. The IST group will receive waist-pulls by a motorized machine to produce stepping. Subjects in the HST group will perform muscle resistance exercises. Subjects in the combined IST and HST will receive both IST and HST interventions. Participants in the SFR group will perform flexibility and relaxation exercises.
|
Combined Induced Step and Hip Strength Training
n=25 participants at risk
This training group consists of combined induced step training (IST) and hip AB-AD strength training (HST).
Physical Training Interventions: Subjects will be assigned to one of four training groups. Training will occur three times weekly for twelve consecutive weeks. The IST group will receive waist-pulls by a motorized machine to produce stepping. Subjects in the HST group will perform muscle resistance exercises. Subjects in the combined IST and HST will receive both IST and HST interventions. Participants in the SFR group will perform flexibility and relaxation exercises.
|
Standard Flexibility and Relaxation (SFR)
n=26 participants at risk
The SFR group will perform a flexibility and relaxation program involving minimal-intensity exercises.
Physical Training Interventions: Subjects will be assigned to one of four training groups. Training will occur three times weekly for twelve consecutive weeks. The IST group will receive waist-pulls by a motorized machine to produce stepping. Subjects in the HST group will perform muscle resistance exercises. Subjects in the combined IST and HST will receive both IST and HST interventions. Participants in the SFR group will perform flexibility and relaxation exercises.
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Low Back Pain
|
0.00%
0/25 • 18 months
|
0.00%
0/26 • 18 months
|
4.0%
1/25 • 18 months
|
3.8%
1/26 • 18 months
|
|
Skin and subcutaneous tissue disorders
R Leg Bruise
|
0.00%
0/25 • 18 months
|
3.8%
1/26 • 18 months
|
0.00%
0/25 • 18 months
|
0.00%
0/26 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Fall
|
0.00%
0/25 • 18 months
|
3.8%
1/26 • 18 months
|
4.0%
1/25 • 18 months
|
0.00%
0/26 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Quad and Hip Abductor Soreness
|
0.00%
0/25 • 18 months
|
3.8%
1/26 • 18 months
|
0.00%
0/25 • 18 months
|
0.00%
0/26 • 18 months
|
|
Musculoskeletal and connective tissue disorders
R Knee Pain
|
4.0%
1/25 • 18 months
|
3.8%
1/26 • 18 months
|
0.00%
0/25 • 18 months
|
0.00%
0/26 • 18 months
|
|
Skin and subcutaneous tissue disorders
R Arm Abrasion
|
4.0%
1/25 • 18 months
|
0.00%
0/26 • 18 months
|
0.00%
0/25 • 18 months
|
0.00%
0/26 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Hip Pain
|
4.0%
1/25 • 18 months
|
0.00%
0/26 • 18 months
|
4.0%
1/25 • 18 months
|
0.00%
0/26 • 18 months
|
|
Reproductive system and breast disorders
Redness/Swelling of Scrotum
|
4.0%
1/25 • 18 months
|
0.00%
0/26 • 18 months
|
0.00%
0/25 • 18 months
|
0.00%
0/26 • 18 months
|
|
Gastrointestinal disorders
Belching/Burping
|
4.0%
1/25 • 18 months
|
0.00%
0/26 • 18 months
|
0.00%
0/25 • 18 months
|
0.00%
0/26 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Muscle Soreness
|
4.0%
1/25 • 18 months
|
0.00%
0/26 • 18 months
|
0.00%
0/25 • 18 months
|
0.00%
0/26 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Hip Flexor Cramping
|
0.00%
0/25 • 18 months
|
0.00%
0/26 • 18 months
|
4.0%
1/25 • 18 months
|
0.00%
0/26 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Abdominal Cramping
|
0.00%
0/25 • 18 months
|
0.00%
0/26 • 18 months
|
4.0%
1/25 • 18 months
|
0.00%
0/26 • 18 months
|
Additional Information
Dr. Vicki Gray Principal Investigator
University of Maryland
Phone: 4107063778
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place