Trial Outcomes & Findings for Working to Increase Stability Through Exercise (NCT NCT02714257)

Last Updated: 2025-02-05

Results Overview

Every 4 months the investigators will call the participants asking questions about the main outcome, FF/SFI. A fall calendar will be given to the participant to record all fall events (e.g., date, location). This will help participants to recall falls during the 4 month period. In addition, this will allow medical records to be requested, using a signed authorization form (part of the consent form). The investigators will review all relevant Electronic Health Records (EHR) information, such as hospital and emergency department discharge summaries, outpatient visit notes, consultation notes, physical exam notes, dictated radiologist notes and plain film radiography.

Recruitment status

COMPLETED

Study phase

Target enrollment

1139 participants

Primary outcome timeframe

36 months

Results posted on

2025-02-05

Participant Flow

Participant milestones

Participant milestones
Measure	Enhanced Usual Care - Control Group Participants will receive enhanced usual care by reviewing three printed pamphlets on fall risks and recommendation to exercise. In addition, to maximize patient safety, the investigators will communicate the baseline bone density results (measured by Dual-energy X-ray absorptiometry, DXA) to the patient's primary care provider, and any critical values of a baseline measure.	Enhanced Usual Care Plus Exercise Coaching Intervention Participants will receive the 3 printed pamphlets on fall risks and exercising in groups (same as the controls) plus: (1) an exercise program that includes strength, balance, and aerobic exercises; (2) an exercise coach that provides in-person and telephone support/feedbacks to enhance participation in the exercise program; and (3) regular progress reports sent by coaches by fax/Electronic Health Records every 4 months, to communicate the patient's progress. Enhanced Usual Care plus Exercise Coaching: For month 1 of the exercise intervention the investigators will conduct only strength and a few balance exercises to rehabilitate the participants. After the first month, and once the participants feel comfortable, the investigators will incorporate aerobic and additional balance exercises. The investigators will personalize participant programs based on baseline levels and increase them gradually. The exercise session will be conducted 50 minutes 3 times a week. Between sets there is a 60-second break. Every month the coach will record steps from the pedometer and record patient adherence to exercise sessions, and every 2 months the coach will measure strength and will track resistance band color from the exercise trackers. For the individuals exercising at home, the investigators will distribute the exercise DVDs every 9 months and the coach will continue to contact them, just as if they were joining the group. Coaches will encourage group participation.
Overall Study STARTED	569	570
Overall Study COMPLETED	559	549
Overall Study NOT COMPLETED	10	21

Reasons for withdrawal

Reasons for withdrawal
Measure	Enhanced Usual Care - Control Group Participants will receive enhanced usual care by reviewing three printed pamphlets on fall risks and recommendation to exercise. In addition, to maximize patient safety, the investigators will communicate the baseline bone density results (measured by Dual-energy X-ray absorptiometry, DXA) to the patient's primary care provider, and any critical values of a baseline measure.	Enhanced Usual Care Plus Exercise Coaching Intervention Participants will receive the 3 printed pamphlets on fall risks and exercising in groups (same as the controls) plus: (1) an exercise program that includes strength, balance, and aerobic exercises; (2) an exercise coach that provides in-person and telephone support/feedbacks to enhance participation in the exercise program; and (3) regular progress reports sent by coaches by fax/Electronic Health Records every 4 months, to communicate the patient's progress. Enhanced Usual Care plus Exercise Coaching: For month 1 of the exercise intervention the investigators will conduct only strength and a few balance exercises to rehabilitate the participants. After the first month, and once the participants feel comfortable, the investigators will incorporate aerobic and additional balance exercises. The investigators will personalize participant programs based on baseline levels and increase them gradually. The exercise session will be conducted 50 minutes 3 times a week. Between sets there is a 60-second break. Every month the coach will record steps from the pedometer and record patient adherence to exercise sessions, and every 2 months the coach will measure strength and will track resistance band color from the exercise trackers. For the individuals exercising at home, the investigators will distribute the exercise DVDs every 9 months and the coach will continue to contact them, just as if they were joining the group. Coaches will encourage group participation.
Overall Study Withdrawal by Subject	6	11
Overall Study Death	3	4
Overall Study Lost to Follow-up	1	6

Baseline Characteristics

Data are missing for 29 participants, 13 in the exercise group and 16 in the control group.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Enhanced Usual Care - Control Group n=569 Participants Participants will receive enhanced usual care by reviewing three printed pamphlets on fall risks and recommendation to exercise. In addition, to maximize patient safety, the investigators will communicate the baseline bone density results (measured by Dual-energy X-ray absorptiometry, DXA) to the patient's primary care provider, and any critical values of a baseline measure.	Enhanced Usual Care Plus Exercise Coaching Intervention n=570 Participants Participants will receive the 3 printed pamphlets on fall risks and exercising in groups (same as the controls) plus: (1) an exercise program that includes strength, balance, and aerobic exercises; (2) an exercise coach that provides in-person and telephone support/feedbacks to enhance participation in the exercise program; and (3) regular progress reports sent by coaches by fax/Electronic Health Records every 4 months, to communicate the patient's progress. Enhanced Usual Care plus Exercise Coaching: For month 1 of the exercise intervention the investigators will conduct only strength and a few balance exercises to rehabilitate the participants. After the first month, and once the participants feel comfortable, the investigators will incorporate aerobic and additional balance exercises. The investigators will personalize participant programs based on baseline levels and increase them gradually. The exercise session will be conducted 50 minutes 3 times a week. Between sets there is a 60-second break. Every month the coach will record steps from the pedometer and record patient adherence to exercise sessions, and every 2 months the coach will measure strength and will track resistance band color from the exercise trackers. For the individuals exercising at home, the investigators will distribute the exercise DVDs every 9 months and the coach will continue to contact them, just as if they were joining the group. Coaches will encourage group participation.	Total n=1139 Participants Total of all reporting groups
Age, Continuous	73.2 years STANDARD_DEVIATION 6.6 • n=569 Participants	73.2 years STANDARD_DEVIATION 6.3 • n=570 Participants	73.2 years STANDARD_DEVIATION 6.4 • n=1139 Participants
Sex: Female, Male Female	479 Participants n=569 Participants	482 Participants n=570 Participants	961 Participants n=1139 Participants
Sex: Female, Male Male	90 Participants n=569 Participants	88 Participants n=570 Participants	178 Participants n=1139 Participants
Race/Ethnicity, Customized White	517 Participants n=569 Participants	508 Participants n=570 Participants	1025 Participants n=1139 Participants
Race/Ethnicity, Customized Black or African-American	28 Participants n=569 Participants	41 Participants n=570 Participants	69 Participants n=1139 Participants
Race/Ethnicity, Customized Asian	6 Participants n=569 Participants	3 Participants n=570 Participants	9 Participants n=1139 Participants
Race/Ethnicity, Customized More than One Race	4 Participants n=569 Participants	8 Participants n=570 Participants	12 Participants n=1139 Participants
Race/Ethnicity, Customized Missing	14 Participants n=569 Participants	10 Participants n=570 Participants	24 Participants n=1139 Participants
Region of Enrollment United States	569 participants n=569 Participants	570 participants n=570 Participants	1139 participants n=1139 Participants
Education Level Less than high school	112 Participants n=569 Participants	92 Participants n=570 Participants	204 Participants n=1139 Participants
Education Level College, 1-3 years	155 Participants n=569 Participants	146 Participants n=570 Participants	301 Participants n=1139 Participants
Education Level College, 4 or more years	291 Participants n=569 Participants	323 Participants n=570 Participants	614 Participants n=1139 Participants
Education Level Missing	11 Participants n=569 Participants	9 Participants n=570 Participants	20 Participants n=1139 Participants
Marital Status Married/Living with partner	295 Participants n=569 Participants	299 Participants n=570 Participants	594 Participants n=1139 Participants
Marital Status Divorced/Separated	104 Participants n=569 Participants	86 Participants n=570 Participants	190 Participants n=1139 Participants
Marital Status Widowed	122 Participants n=569 Participants	117 Participants n=570 Participants	239 Participants n=1139 Participants
Marital Status Never married	34 Participants n=569 Participants	55 Participants n=570 Participants	89 Participants n=1139 Participants
Marital Status Missing	14 Participants n=569 Participants	13 Participants n=570 Participants	27 Participants n=1139 Participants
Body Mass Index (BMI)	28.6 kg/m^2 STANDARD_DEVIATION 6.5 • n=553 Participants • Data are missing for 29 participants, 13 in the exercise group and 16 in the control group.	28.6 kg/m^2 STANDARD_DEVIATION 6.5 • n=557 Participants • Data are missing for 29 participants, 13 in the exercise group and 16 in the control group.	28.6 kg/m^2 STANDARD_DEVIATION 6.5 • n=1110 Participants • Data are missing for 29 participants, 13 in the exercise group and 16 in the control group.
Systolic Blood Pressure	129.7 mmHg STANDARD_DEVIATION 17.7 • n=569 Participants	129.4 mmHg STANDARD_DEVIATION 17.8 • n=570 Participants	129.5 mmHg STANDARD_DEVIATION 17.8 • n=1139 Participants
History of Osteoporosis Yes	261 Participants n=569 Participants	270 Participants n=570 Participants	531 Participants n=1139 Participants
History of Osteoporosis No	295 Participants n=569 Participants	292 Participants n=570 Participants	587 Participants n=1139 Participants
History of Osteoporosis Missing	13 Participants n=569 Participants	8 Participants n=570 Participants	21 Participants n=1139 Participants
Any fall in past year Yes	271 Participants n=569 Participants	290 Participants n=570 Participants	561 Participants n=1139 Participants
Any fall in past year No	283 Participants n=569 Participants	262 Participants n=570 Participants	545 Participants n=1139 Participants
Any fall in past year Missing	15 Participants n=569 Participants	18 Participants n=570 Participants	33 Participants n=1139 Participants

PRIMARY outcome

Timeframe: 36 months

Population: All randomized participants

Outcome measures

Outcome measures
Measure	Enhanced Usual Care - Control Group n=569 Participants Participants will receive enhanced usual care by reviewing three printed pamphlets on fall risks and recommendation to exercise. In addition, to maximize patient safety, the investigators will communicate the baseline bone density results (measured by Dual-energy X-ray absorptiometry, DXA) to the patient's primary care provider, and any critical values of a baseline measure.	Enhanced Usual Care Plus Exercise Coaching Intervention n=570 Participants Participants will receive the 3 printed pamphlets on fall risks and exercising in groups (same as the controls) plus: (1) an exercise program that includes strength, balance, and aerobic exercises; (2) an exercise coach that provides in-person and telephone support/feedbacks to enhance participation in the exercise program; and (3) regular progress reports sent by coaches by fax/Electronic Health Records every 4 months, to communicate the patient's progress. Enhanced Usual Care plus Exercise Coaching: For month 1 of the exercise intervention the investigators will conduct only strength and a few balance exercises to rehabilitate the participants. After the first month, and once the participants feel comfortable, the investigators will incorporate aerobic and additional balance exercises. The investigators will personalize participant programs based on baseline levels and increase them gradually. The exercise session will be conducted 50 minutes 3 times a week. Between sets there is a 60-second break. Every month the coach will record steps from the pedometer and record patient adherence to exercise sessions, and every 2 months the coach will measure strength and will track resistance band color from the exercise trackers. For the individuals exercising at home, the investigators will distribute the exercise DVDs every 9 months and the coach will continue to contact them, just as if they were joining the group. Coaches will encourage group participation.
Number of Participants Experiencing Fragility Fractures and Serious Fall-Related Injuries (FF/SFI)	186 Participants	166 Participants

SECONDARY outcome

Timeframe: 36 months

The investigators will examine the number of falls, and fall-related injuries using two questions from the BRFSS.

Outcome measures

Outcome measures
Measure	Enhanced Usual Care - Control Group n=531 Participants Participants will receive enhanced usual care by reviewing three printed pamphlets on fall risks and recommendation to exercise. In addition, to maximize patient safety, the investigators will communicate the baseline bone density results (measured by Dual-energy X-ray absorptiometry, DXA) to the patient's primary care provider, and any critical values of a baseline measure.	Enhanced Usual Care Plus Exercise Coaching Intervention n=495 Participants Participants will receive the 3 printed pamphlets on fall risks and exercising in groups (same as the controls) plus: (1) an exercise program that includes strength, balance, and aerobic exercises; (2) an exercise coach that provides in-person and telephone support/feedbacks to enhance participation in the exercise program; and (3) regular progress reports sent by coaches by fax/Electronic Health Records every 4 months, to communicate the patient's progress. Enhanced Usual Care plus Exercise Coaching: For month 1 of the exercise intervention the investigators will conduct only strength and a few balance exercises to rehabilitate the participants. After the first month, and once the participants feel comfortable, the investigators will incorporate aerobic and additional balance exercises. The investigators will personalize participant programs based on baseline levels and increase them gradually. The exercise session will be conducted 50 minutes 3 times a week. Between sets there is a 60-second break. Every month the coach will record steps from the pedometer and record patient adherence to exercise sessions, and every 2 months the coach will measure strength and will track resistance band color from the exercise trackers. For the individuals exercising at home, the investigators will distribute the exercise DVDs every 9 months and the coach will continue to contact them, just as if they were joining the group. Coaches will encourage group participation.
Number of Falls and Falls-related Injuries Using the Behavioral Risk Factor Surveillance System (BRFSS)	0.87 falls Interval 0.79 to 0.95	0.84 falls Interval 0.76 to 0.93

SECONDARY outcome

Timeframe: 36 months

The investigators will use a self-reported health question to assess key patient centered outcomes that the intervention may improve. This question is from the NIH-supported PROMIS. The outcome is categorized as excellent/very good health vs. good/fair/poor health as reported on the single question.

Outcome measures

Outcome measures
Measure	Enhanced Usual Care - Control Group n=539 Participants Participants will receive enhanced usual care by reviewing three printed pamphlets on fall risks and recommendation to exercise. In addition, to maximize patient safety, the investigators will communicate the baseline bone density results (measured by Dual-energy X-ray absorptiometry, DXA) to the patient's primary care provider, and any critical values of a baseline measure.	Enhanced Usual Care Plus Exercise Coaching Intervention n=506 Participants Participants will receive the 3 printed pamphlets on fall risks and exercising in groups (same as the controls) plus: (1) an exercise program that includes strength, balance, and aerobic exercises; (2) an exercise coach that provides in-person and telephone support/feedbacks to enhance participation in the exercise program; and (3) regular progress reports sent by coaches by fax/Electronic Health Records every 4 months, to communicate the patient's progress. Enhanced Usual Care plus Exercise Coaching: For month 1 of the exercise intervention the investigators will conduct only strength and a few balance exercises to rehabilitate the participants. After the first month, and once the participants feel comfortable, the investigators will incorporate aerobic and additional balance exercises. The investigators will personalize participant programs based on baseline levels and increase them gradually. The exercise session will be conducted 50 minutes 3 times a week. Between sets there is a 60-second break. Every month the coach will record steps from the pedometer and record patient adherence to exercise sessions, and every 2 months the coach will measure strength and will track resistance band color from the exercise trackers. For the individuals exercising at home, the investigators will distribute the exercise DVDs every 9 months and the coach will continue to contact them, just as if they were joining the group. Coaches will encourage group participation.
Percentage of Participants With Excellent/Very Good Health Using the Patient Reported Outcomes Measurement Information System (PROMIS)	52.2 Percentage of participants	54.3 Percentage of participants

SECONDARY outcome

Timeframe: 36 months

The investigators will use the 7-item version of the Falls Efficacy Scale International (FES-I), used to quantify fear of falling in 7 different scenarios. Each item is scored 1-4, with higher scores being associated with greater fear. Total sum score is reported, possible range 7-28.

Outcome measures

Outcome measures
Measure	Enhanced Usual Care - Control Group n=539 Participants Participants will receive enhanced usual care by reviewing three printed pamphlets on fall risks and recommendation to exercise. In addition, to maximize patient safety, the investigators will communicate the baseline bone density results (measured by Dual-energy X-ray absorptiometry, DXA) to the patient's primary care provider, and any critical values of a baseline measure.	Enhanced Usual Care Plus Exercise Coaching Intervention n=506 Participants Participants will receive the 3 printed pamphlets on fall risks and exercising in groups (same as the controls) plus: (1) an exercise program that includes strength, balance, and aerobic exercises; (2) an exercise coach that provides in-person and telephone support/feedbacks to enhance participation in the exercise program; and (3) regular progress reports sent by coaches by fax/Electronic Health Records every 4 months, to communicate the patient's progress. Enhanced Usual Care plus Exercise Coaching: For month 1 of the exercise intervention the investigators will conduct only strength and a few balance exercises to rehabilitate the participants. After the first month, and once the participants feel comfortable, the investigators will incorporate aerobic and additional balance exercises. The investigators will personalize participant programs based on baseline levels and increase them gradually. The exercise session will be conducted 50 minutes 3 times a week. Between sets there is a 60-second break. Every month the coach will record steps from the pedometer and record patient adherence to exercise sessions, and every 2 months the coach will measure strength and will track resistance band color from the exercise trackers. For the individuals exercising at home, the investigators will distribute the exercise DVDs every 9 months and the coach will continue to contact them, just as if they were joining the group. Coaches will encourage group participation.
Assessment of Fear of Falling Using the Falls Efficacy Scale International (FES-I)	11.65 score on a scale Interval 10.96 to 12.33	11.11 score on a scale Interval 10.45 to 11.77

SECONDARY outcome

Timeframe: 36 months

The investigators will use 6 questions from the NHIS at baseline and the 36 month follow-up to measure participants' activity level. Percentage of participants with a sum of moderate and vigorous minutes \>=150 is reported.

Outcome measures

Outcome measures
Measure	Enhanced Usual Care - Control Group n=529 Participants Participants will receive enhanced usual care by reviewing three printed pamphlets on fall risks and recommendation to exercise. In addition, to maximize patient safety, the investigators will communicate the baseline bone density results (measured by Dual-energy X-ray absorptiometry, DXA) to the patient's primary care provider, and any critical values of a baseline measure.	Enhanced Usual Care Plus Exercise Coaching Intervention n=487 Participants Participants will receive the 3 printed pamphlets on fall risks and exercising in groups (same as the controls) plus: (1) an exercise program that includes strength, balance, and aerobic exercises; (2) an exercise coach that provides in-person and telephone support/feedbacks to enhance participation in the exercise program; and (3) regular progress reports sent by coaches by fax/Electronic Health Records every 4 months, to communicate the patient's progress. Enhanced Usual Care plus Exercise Coaching: For month 1 of the exercise intervention the investigators will conduct only strength and a few balance exercises to rehabilitate the participants. After the first month, and once the participants feel comfortable, the investigators will incorporate aerobic and additional balance exercises. The investigators will personalize participant programs based on baseline levels and increase them gradually. The exercise session will be conducted 50 minutes 3 times a week. Between sets there is a 60-second break. Every month the coach will record steps from the pedometer and record patient adherence to exercise sessions, and every 2 months the coach will measure strength and will track resistance band color from the exercise trackers. For the individuals exercising at home, the investigators will distribute the exercise DVDs every 9 months and the coach will continue to contact them, just as if they were joining the group. Coaches will encourage group participation.
Percentage of Participants Meeting Physical Activity Guidelines Using the National Health Interview Survey (NHIS)	50.7 Percentage of participants	50.9 Percentage of participants

SECONDARY outcome

Timeframe: 36 months

The investigators will use 4 physical function questions to assess physical function subscale of PROMIS. Each item ranges 1-5. Total sum score is reported; higher scores are associated with lower levels of physical function. Total sum score range, 4-20.

Outcome measures

Outcome measures
Measure	Enhanced Usual Care - Control Group n=539 Participants Participants will receive enhanced usual care by reviewing three printed pamphlets on fall risks and recommendation to exercise. In addition, to maximize patient safety, the investigators will communicate the baseline bone density results (measured by Dual-energy X-ray absorptiometry, DXA) to the patient's primary care provider, and any critical values of a baseline measure.	Enhanced Usual Care Plus Exercise Coaching Intervention n=506 Participants Participants will receive the 3 printed pamphlets on fall risks and exercising in groups (same as the controls) plus: (1) an exercise program that includes strength, balance, and aerobic exercises; (2) an exercise coach that provides in-person and telephone support/feedbacks to enhance participation in the exercise program; and (3) regular progress reports sent by coaches by fax/Electronic Health Records every 4 months, to communicate the patient's progress. Enhanced Usual Care plus Exercise Coaching: For month 1 of the exercise intervention the investigators will conduct only strength and a few balance exercises to rehabilitate the participants. After the first month, and once the participants feel comfortable, the investigators will incorporate aerobic and additional balance exercises. The investigators will personalize participant programs based on baseline levels and increase them gradually. The exercise session will be conducted 50 minutes 3 times a week. Between sets there is a 60-second break. Every month the coach will record steps from the pedometer and record patient adherence to exercise sessions, and every 2 months the coach will measure strength and will track resistance band color from the exercise trackers. For the individuals exercising at home, the investigators will distribute the exercise DVDs every 9 months and the coach will continue to contact them, just as if they were joining the group. Coaches will encourage group participation.
Assessment of Physical Function Using PROMIS	9.00 Score on a scale Interval 8.28 to 9.72	8.77 Score on a scale Interval 8.08 to 9.47

SECONDARY outcome

Timeframe: 36 months

The investigators will use 4 depression questions to assess key patient centered outcomes that the intervention may improve. These questions are from the NIH-supported PROMIS.

Outcome measures

Outcome measures
Measure	Enhanced Usual Care - Control Group n=539 Participants Participants will receive enhanced usual care by reviewing three printed pamphlets on fall risks and recommendation to exercise. In addition, to maximize patient safety, the investigators will communicate the baseline bone density results (measured by Dual-energy X-ray absorptiometry, DXA) to the patient's primary care provider, and any critical values of a baseline measure.	Enhanced Usual Care Plus Exercise Coaching Intervention n=506 Participants Participants will receive the 3 printed pamphlets on fall risks and exercising in groups (same as the controls) plus: (1) an exercise program that includes strength, balance, and aerobic exercises; (2) an exercise coach that provides in-person and telephone support/feedbacks to enhance participation in the exercise program; and (3) regular progress reports sent by coaches by fax/Electronic Health Records every 4 months, to communicate the patient's progress. Enhanced Usual Care plus Exercise Coaching: For month 1 of the exercise intervention the investigators will conduct only strength and a few balance exercises to rehabilitate the participants. After the first month, and once the participants feel comfortable, the investigators will incorporate aerobic and additional balance exercises. The investigators will personalize participant programs based on baseline levels and increase them gradually. The exercise session will be conducted 50 minutes 3 times a week. Between sets there is a 60-second break. Every month the coach will record steps from the pedometer and record patient adherence to exercise sessions, and every 2 months the coach will measure strength and will track resistance band color from the exercise trackers. For the individuals exercising at home, the investigators will distribute the exercise DVDs every 9 months and the coach will continue to contact them, just as if they were joining the group. Coaches will encourage group participation.
Assessment of Depression Using PROMIS	5.62 score on a scale of 4-20, higher=worse Interval 5.21 to 6.03	5.52 score on a scale of 4-20, higher=worse Interval 5.12 to 5.91

SECONDARY outcome

Timeframe: 36 months

The investigators will use 4 anxiety questions to assess key patient centered outcomes that the intervention may improve. These questions are from the NIH-supported PROMIS.

Outcome measures

Outcome measures
Measure	Enhanced Usual Care - Control Group n=539 Participants Participants will receive enhanced usual care by reviewing three printed pamphlets on fall risks and recommendation to exercise. In addition, to maximize patient safety, the investigators will communicate the baseline bone density results (measured by Dual-energy X-ray absorptiometry, DXA) to the patient's primary care provider, and any critical values of a baseline measure.	Enhanced Usual Care Plus Exercise Coaching Intervention n=506 Participants Participants will receive the 3 printed pamphlets on fall risks and exercising in groups (same as the controls) plus: (1) an exercise program that includes strength, balance, and aerobic exercises; (2) an exercise coach that provides in-person and telephone support/feedbacks to enhance participation in the exercise program; and (3) regular progress reports sent by coaches by fax/Electronic Health Records every 4 months, to communicate the patient's progress. Enhanced Usual Care plus Exercise Coaching: For month 1 of the exercise intervention the investigators will conduct only strength and a few balance exercises to rehabilitate the participants. After the first month, and once the participants feel comfortable, the investigators will incorporate aerobic and additional balance exercises. The investigators will personalize participant programs based on baseline levels and increase them gradually. The exercise session will be conducted 50 minutes 3 times a week. Between sets there is a 60-second break. Every month the coach will record steps from the pedometer and record patient adherence to exercise sessions, and every 2 months the coach will measure strength and will track resistance band color from the exercise trackers. For the individuals exercising at home, the investigators will distribute the exercise DVDs every 9 months and the coach will continue to contact them, just as if they were joining the group. Coaches will encourage group participation.
Assessment of Anxiety Using PROMIS	6.21 score on a scale of 4-20, higher=worse Interval 5.79 to 6.64	6.07 score on a scale of 4-20, higher=worse Interval 5.66 to 6.48

SECONDARY outcome

Timeframe: 36 months

The investigators will use 3 loneliness questions to assess key patient centered outcomes that the intervention may improve. These questions are from the NIH-supported PROMIS.

Outcome measures

Outcome measures
Measure	Enhanced Usual Care - Control Group n=539 Participants Participants will receive enhanced usual care by reviewing three printed pamphlets on fall risks and recommendation to exercise. In addition, to maximize patient safety, the investigators will communicate the baseline bone density results (measured by Dual-energy X-ray absorptiometry, DXA) to the patient's primary care provider, and any critical values of a baseline measure.	Enhanced Usual Care Plus Exercise Coaching Intervention n=506 Participants Participants will receive the 3 printed pamphlets on fall risks and exercising in groups (same as the controls) plus: (1) an exercise program that includes strength, balance, and aerobic exercises; (2) an exercise coach that provides in-person and telephone support/feedbacks to enhance participation in the exercise program; and (3) regular progress reports sent by coaches by fax/Electronic Health Records every 4 months, to communicate the patient's progress. Enhanced Usual Care plus Exercise Coaching: For month 1 of the exercise intervention the investigators will conduct only strength and a few balance exercises to rehabilitate the participants. After the first month, and once the participants feel comfortable, the investigators will incorporate aerobic and additional balance exercises. The investigators will personalize participant programs based on baseline levels and increase them gradually. The exercise session will be conducted 50 minutes 3 times a week. Between sets there is a 60-second break. Every month the coach will record steps from the pedometer and record patient adherence to exercise sessions, and every 2 months the coach will measure strength and will track resistance band color from the exercise trackers. For the individuals exercising at home, the investigators will distribute the exercise DVDs every 9 months and the coach will continue to contact them, just as if they were joining the group. Coaches will encourage group participation.
Assessment of Loneliness Using PROMIS	4.19 score on a scale of 3-9, higher=worse Interval 3.92 to 4.46	4.12 score on a scale of 3-9, higher=worse Interval 3.86 to 4.38

Adverse Events

Enhanced Usual Care - Control Group

Serious events: 162 serious events

Other events: 0 other events

Deaths: 22 deaths

Enhanced Usual Care Plus Exercise Coaching Intervention

Serious events: 79 serious events

Other events: 0 other events

Deaths: 30 deaths

Serious adverse events

Serious adverse events
Measure	Enhanced Usual Care - Control Group n=569 participants at risk Participants will receive enhanced usual care by reviewing three printed pamphlets on fall risks and recommendation to exercise. In addition, to maximize patient safety, the investigators will communicate the baseline bone density results (measured by Dual-energy X-ray absorptiometry, DXA) to the patient's primary care provider, and any critical values of a baseline measure.	Enhanced Usual Care Plus Exercise Coaching Intervention n=570 participants at risk Participants will receive the 3 printed pamphlets on fall risks and exercising in groups (same as the controls) plus: (1) an exercise program that includes strength, balance, and aerobic exercises; (2) an exercise coach that provides in-person and telephone support/feedbacks to enhance participation in the exercise program; and (3) regular progress reports sent by coaches by fax/Electronic Health Records every 4 months, to communicate the patient's progress. Enhanced Usual Care plus Exercise Coaching: For month 1 of the exercise intervention the investigators will conduct only strength and a few balance exercises to rehabilitate the participants. After the first month, and once the participants feel comfortable, the investigators will incorporate aerobic and additional balance exercises. The investigators will personalize participant programs based on baseline levels and increase them gradually. The exercise session will be conducted 50 minutes 3 times a week. Between sets there is a 60-second break. Every month the coach will record steps from the pedometer and record patient adherence to exercise sessions, and every 2 months the coach will measure strength and will track resistance band color from the exercise trackers. For the individuals exercising at home, the investigators will distribute the exercise DVDs every 9 months and the coach will continue to contact them, just as if they were joining the group. Coaches will encourage group participation.
Musculoskeletal and connective tissue disorders Fracture	4.4% 25/569 • Number of events 27 • Data were collected every 4 months for the full 36-month duration of study participation. Data were collected via structured phone interview which included the use of a calendar used to track falls, specifically.	0.35% 2/570 • Number of events 2 • Data were collected every 4 months for the full 36-month duration of study participation. Data were collected via structured phone interview which included the use of a calendar used to track falls, specifically.
Musculoskeletal and connective tissue disorders Elective Joint Replacement	3.2% 18/569 • Number of events 18 • Data were collected every 4 months for the full 36-month duration of study participation. Data were collected via structured phone interview which included the use of a calendar used to track falls, specifically.	0.53% 3/570 • Number of events 3 • Data were collected every 4 months for the full 36-month duration of study participation. Data were collected via structured phone interview which included the use of a calendar used to track falls, specifically.
Surgical and medical procedures Other Surgery	2.5% 14/569 • Number of events 16 • Data were collected every 4 months for the full 36-month duration of study participation. Data were collected via structured phone interview which included the use of a calendar used to track falls, specifically.	0.70% 4/570 • Number of events 4 • Data were collected every 4 months for the full 36-month duration of study participation. Data were collected via structured phone interview which included the use of a calendar used to track falls, specifically.
Infections and infestations Infection	3.5% 20/569 • Number of events 23 • Data were collected every 4 months for the full 36-month duration of study participation. Data were collected via structured phone interview which included the use of a calendar used to track falls, specifically.	2.1% 12/570 • Number of events 13 • Data were collected every 4 months for the full 36-month duration of study participation. Data were collected via structured phone interview which included the use of a calendar used to track falls, specifically.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm	0.53% 3/569 • Number of events 3 • Data were collected every 4 months for the full 36-month duration of study participation. Data were collected via structured phone interview which included the use of a calendar used to track falls, specifically.	0.35% 2/570 • Number of events 2 • Data were collected every 4 months for the full 36-month duration of study participation. Data were collected via structured phone interview which included the use of a calendar used to track falls, specifically.
Cardiac disorders Atrial Fibrillation/Flutter	0.18% 1/569 • Number of events 1 • Data were collected every 4 months for the full 36-month duration of study participation. Data were collected via structured phone interview which included the use of a calendar used to track falls, specifically.	0.70% 4/570 • Number of events 4 • Data were collected every 4 months for the full 36-month duration of study participation. Data were collected via structured phone interview which included the use of a calendar used to track falls, specifically.
Cardiac disorders Heart Failure	1.2% 7/569 • Number of events 7 • Data were collected every 4 months for the full 36-month duration of study participation. Data were collected via structured phone interview which included the use of a calendar used to track falls, specifically.	0.53% 3/570 • Number of events 4 • Data were collected every 4 months for the full 36-month duration of study participation. Data were collected via structured phone interview which included the use of a calendar used to track falls, specifically.
Cardiac disorders Acute Coronary Syndrome / Myocardial Infarction	0.88% 5/569 • Number of events 5 • Data were collected every 4 months for the full 36-month duration of study participation. Data were collected via structured phone interview which included the use of a calendar used to track falls, specifically.	0.35% 2/570 • Number of events 3 • Data were collected every 4 months for the full 36-month duration of study participation. Data were collected via structured phone interview which included the use of a calendar used to track falls, specifically.
Cardiac disorders Stroke / Transient Ischemic Attack / Intracranial Hemorrhage	1.9% 11/569 • Number of events 12 • Data were collected every 4 months for the full 36-month duration of study participation. Data were collected via structured phone interview which included the use of a calendar used to track falls, specifically.	0.18% 1/570 • Number of events 1 • Data were collected every 4 months for the full 36-month duration of study participation. Data were collected via structured phone interview which included the use of a calendar used to track falls, specifically.
General disorders Fluid / Electrolyte Abnormality	0.35% 2/569 • Number of events 2 • Data were collected every 4 months for the full 36-month duration of study participation. Data were collected via structured phone interview which included the use of a calendar used to track falls, specifically.	0.53% 3/570 • Number of events 3 • Data were collected every 4 months for the full 36-month duration of study participation. Data were collected via structured phone interview which included the use of a calendar used to track falls, specifically.
General disorders Dehydration	0.35% 2/569 • Number of events 2 • Data were collected every 4 months for the full 36-month duration of study participation. Data were collected via structured phone interview which included the use of a calendar used to track falls, specifically.	0.00% 0/570 • Data were collected every 4 months for the full 36-month duration of study participation. Data were collected via structured phone interview which included the use of a calendar used to track falls, specifically.
General disorders Imbalance (syncope, dizziness, vertigo)	0.53% 3/569 • Number of events 3 • Data were collected every 4 months for the full 36-month duration of study participation. Data were collected via structured phone interview which included the use of a calendar used to track falls, specifically.	1.1% 6/570 • Number of events 6 • Data were collected every 4 months for the full 36-month duration of study participation. Data were collected via structured phone interview which included the use of a calendar used to track falls, specifically.
General disorders Other	9.0% 51/569 • Number of events 65 • Data were collected every 4 months for the full 36-month duration of study participation. Data were collected via structured phone interview which included the use of a calendar used to track falls, specifically.	6.5% 37/570 • Number of events 45 • Data were collected every 4 months for the full 36-month duration of study participation. Data were collected via structured phone interview which included the use of a calendar used to track falls, specifically.

Other adverse events

Adverse event data not reported

Additional Information

Christopher Sciamanna, MD, MPH

Milton S. Hershey Medical Center

Phone: 717-531-4417

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place