Trial Outcomes & Findings for Life 2: Improving Fitness and Function in Elders (NCT NCT00435188)

NCT ID: NCT00435188

Last Updated: 2015-01-09

Results Overview

Best of two trials over 8-foot walk

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 400 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2015-01-09

Participant Flow

Participant milestones

Measure	Arm 1, Physical Activity Counseling Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback	Arm 2, Usual Care Usual care participants were asked to continue their normal activities and offered a 3-month physical activity counseling program upon completion of the trial
Overall Study STARTED	199	199
Overall Study COMPLETED	177	176
Overall Study NOT COMPLETED	22	23

Reasons for withdrawal

Measure	Arm 1, Physical Activity Counseling Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback	Arm 2, Usual Care Usual care participants were asked to continue their normal activities and offered a 3-month physical activity counseling program upon completion of the trial
Overall Study Death	1	6
Overall Study Withdrawal by Subject	16	11
Overall Study Lost to Follow-up	5	6

Baseline Characteristics

Life 2: Improving Fitness and Function in Elders

Baseline characteristics by cohort

Measure	Arm 1 n=199 Participants Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic vis	Arm 2 n=199 Participants Usual care	Total n=398 Participants Total of all reporting groups
Age, Continuous	77.7 years STANDARD_DEVIATION 5.0 • n=5 Participants	77.4 years STANDARD_DEVIATION 4.9 • n=7 Participants	77.5 years STANDARD_DEVIATION 5 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	199 Participants n=5 Participants	199 Participants n=7 Participants	398 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	48 Participants n=5 Participants	42 Participants n=7 Participants	90 Participants n=5 Participants
Race (NIH/OMB) White	151 Participants n=5 Participants	157 Participants n=7 Participants	308 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	199 participants n=5 Participants	199 participants n=7 Participants	398 participants n=5 Participants
Education Less or equal to high school	91 participants n=5 Participants	92 participants n=7 Participants	183 participants n=5 Participants
Education Some college or trade school	56 participants n=5 Participants	52 participants n=7 Participants	108 participants n=5 Participants
Education College graduate	52 participants n=5 Participants	55 participants n=7 Participants	107 participants n=5 Participants
Body mass index	28.9 kg/m2 STANDARD_DEVIATION 4.7 • n=5 Participants	29.1 kg/m2 STANDARD_DEVIATION 4.6 • n=7 Participants	29 kg/m2 STANDARD_DEVIATION 4.6 • n=5 Participants
Number of diseases	5.2 Diseases STANDARD_DEVIATION 2.5 • n=5 Participants	5.5 Diseases STANDARD_DEVIATION 2.7 • n=7 Participants	5.3 Diseases STANDARD_DEVIATION 2.6 • n=5 Participants
Health quality of life of excellent or very good Health QOL rated as Excellent or Very Good	71 participants n=5 Participants	76 participants n=7 Participants	147 participants n=5 Participants
Health quality of life of excellent or very good Health QOL rated as Good, Fair, or Poor	128 participants n=5 Participants	123 participants n=7 Participants	251 participants n=5 Participants
Assistive device Participants reporting assistive device use	40 participants n=5 Participants	39 participants n=7 Participants	79 participants n=5 Participants
Assistive device Participants reporting no use of assistive devices	159 participants n=5 Participants	160 participants n=7 Participants	319 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Best of two trials over 8-foot walk

Outcome measures

Measure	Arm 1 n=199 Participants Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback	Arm 2 n=199 Participants Usual care
Usual Gait Speed	1.03 meters/second Standard Deviation 0.25	1.03 meters/second Standard Deviation 0.24

PRIMARY outcome

Timeframe: 3 month

Outcome measures

Measure	Arm 1 n=184 Participants Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback	Arm 2 n=189 Participants Usual care
Usual Gait Speed	1.09 meters/second Standard Deviation 0.29	1.07 meters/second Standard Deviation 0.28

PRIMARY outcome

Timeframe: 12-month

Outcome measures

Measure	Arm 1 n=178 Participants Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback	Arm 2 n=177 Participants Usual care
Usual Gait Speed	1.15 meters/second Standard Deviation 0.28	1.12 meters/second Standard Deviation 0.25

PRIMARY outcome

Timeframe: Baseline

Outcome measures

Measure	Arm 1 n=199 Participants Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback	Arm 2 n=199 Participants Usual care
Rapid Gait Speed	1.56 meters/second Standard Deviation 0.41	1.57 meters/second Standard Deviation 0.4

PRIMARY outcome

Timeframe: 3-month

Outcome measures

Measure	Arm 1 n=184 Participants Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback	Arm 2 n=189 Participants Usual care
Rapid Gait Speed	1.62 meters/second Standard Deviation 0.5	1.58 meters/second Standard Deviation 0.42

PRIMARY outcome

Timeframe: 12-month

Outcome measures

Measure	Arm 1 n=178 Participants Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback	Arm 2 n=177 Participants Usual care
Rapid Gait Speed	1.68 meters/second Standard Deviation 0.44	1.59 meters/second Standard Deviation 0.42

SECONDARY outcome

Timeframe: Baseline

Exercise frequency derived from Community Healthy Activities Model Program for Seniors (CHAMPS) questionnaire; The Champs assesses the frequency of a range of physical activities

Outcome measures

Measure	Arm 1 n=199 Participants Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback	Arm 2 n=199 Participants Usual care
Physical Activity Frequency (CHAMPS Questionnaire)	15.9 times per week Standard Deviation 9.4	16.8 times per week Standard Deviation 9.8

SECONDARY outcome

Timeframe: 3 month

Exercise frequency derived from Community Healthy Activities Model Program for Seniors (CHAMPS) questionnaire; The Champs assesses the frequency of a range of physical activities

Outcome measures

Measure	Arm 1 n=184 Participants Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback	Arm 2 n=189 Participants Usual care
Physical Activity Frequency (CHAMPS Questionnaire)	22.7 times per week Standard Deviation 9.8	17.6 times per week Standard Deviation 9.4

SECONDARY outcome

Timeframe: 12 month

Exercise frequency derived from Community Healthy Activities Model Program for Seniors (CHAMPS) questionnaire; The Champs assesses the frequency of a range of physical activities

Outcome measures

Measure	Arm 1 n=178 Participants Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback	Arm 2 n=177 Participants Usual care
Physical Activity Frequency (CHAMPS Questionnaire)	22.4 times per week Standard Deviation 12	16.8 times per week Standard Deviation 9.2

SECONDARY outcome

Timeframe: Baseline

Self-report of overall health, reported as the number of participants reporting health as Excellent or Very good

Outcome measures

Measure	Arm 1 n=199 Participants Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback	Arm 2 n=199 Participants Usual care
Self Rated Health Overall health is excellent or very good	71 participants	76 participants
Self Rated Health Overall health is good, fair or poor	128 participants	123 participants

SECONDARY outcome

Timeframe: 3 month

Self-report of overall health, reported as the number of participants reporting health as Excellent or Very good

Outcome measures

Measure	Arm 1 n=184 Participants Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback	Arm 2 n=189 Participants Usual care
Self Rated Health Overall health is excellent or very good	82 participants	75 participants
Self Rated Health Overall health is good, fair or poor	102 participants	114 participants

SECONDARY outcome

Timeframe: 12 month

Self-report of overall health, reported as the number of participants reporting health as Excellent or Very good

Outcome measures

Measure	Arm 1 n=178 Participants Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback	Arm 2 n=177 Participants Usual care
Self Rated Health Overall health is excellent or very good	78 participants	70 participants
Self Rated Health Overall health is good, fair or poor	100 participants	107 participants

SECONDARY outcome

Timeframe: Baseline

This is a subscale of the SF-36 Medical Outcomes Study. The Physical Function subscale assesses a self-reported ability to perform physical tasks. It is normalized for scores to range from 0 to 100 with a higher score indicating better function.

Outcome measures

Measure	Arm 1 n=199 Participants Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback	Arm 2 n=199 Participants Usual care
Sf-36 Physical Function Subscale	68 units on a scale Standard Deviation 22.2	62.9 units on a scale Standard Deviation 23.1

SECONDARY outcome

Timeframe: 3 month

This is a subscale of the SF-36 Medical Outcomes Study. The Physical Function subscale assesses a self-reported ability to perform physical tasks. It is normalized for scores to range from 0 to 100 with a higher score indicating better function.

Outcome measures

Measure	Arm 1 n=184 Participants Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback	Arm 2 n=189 Participants Usual care
Sf-36 Physical Function Subscale	70 units on a scale Standard Deviation 22.4	63.1 units on a scale Standard Deviation 24

SECONDARY outcome

Timeframe: 12 month

This is a subscale of the SF-36 Medical Outcomes Study. The Physical Function subscale assesses a self-reported ability to perform physical tasks. It is normalized for scores to range from 0 to 100 with a higher score indicating better function.

Outcome measures

Measure	Arm 1 n=178 Participants Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback	Arm 2 n=177 Participants Usual care
Sf-36 Physical Function Subscale	69.9 units on a scale Standard Deviation 22.1	62.7 units on a scale Standard Deviation 23.8

SECONDARY outcome

Timeframe: Baseline

Distance walked in two minutes in meters

Outcome measures

Measure	Arm 1 n=199 Participants Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback	Arm 2 n=199 Participants Usual care
2 Minute Walk	146 meters Standard Deviation 36.3	145.4 meters Standard Deviation 32.8

SECONDARY outcome

Timeframe: 3 month

Distance walked in two minutes in meters

Outcome measures

Measure	Arm 1 n=184 Participants Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback	Arm 2 n=189 Participants Usual care
2 Minute Walk	151.7 meters Standard Deviation 37.8	145.6 meters Standard Deviation 34.9

SECONDARY outcome

Timeframe: 12 month

Distance walked in two minutes in meters

Outcome measures

Measure	Arm 1 n=178 Participants Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback	Arm 2 n=177 Participants Usual care
2 Minute Walk	150.9 meters Standard Deviation 38.5	147.5 meters Standard Deviation 34.7

Adverse Events

Arm 1, Physical Activity Counseling

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Arm 2, Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Arm 1, Physical Activity Counseling n=199 participants at risk Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback	Arm 2, Usual Care n=199 participants at risk Usual care participants were asked to continue their normal activities and offered a 3-month physical activity counseling program upon completion of the trial
Musculoskeletal and connective tissue disorders minor injury	1.5% 3/199 • 12 months	0.00% 0/199 • 12 months

Additional Information

Miriam C. Morey, Ph.D.

Durham VA Research and Development

Phone: 919-286-0411

Email: miriam.morey@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place