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Seniors Health and Activity Research Program-Pilot (SHARP-P)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00688155
First Posted: June 2, 2008
Last Update Posted: December 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Wake Forest University Health Sciences
Results First Submitted: May 25, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Prevention
Condition: Cognitive Function
Interventions: Behavioral: Physical Activity Training
Behavioral: Cognitive Training
Behavioral: Healthy Aging Education

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Physical Activity Training

The Physical Activity Training ((PAT) intervention consisted of center-based and home-based sessions comprised of aerobic, strength, flexibility, and balance training with a targeted duration of 150 minutes/week. It included two center and two home-based training sessions per week for four months. Its primary focus was walking with the explicit intent of improving cardiovascular fitness. Other forms of endurance activity (e.g., stationary cycling) were used when regular walking was contraindicated for medical or behavioral reasons. Center-based physical activity sessions were supplemented with additional tailored home-based walking sessions at 1-2 per week during the first month.

Physical Activity Training (PAT): Two 1-hour center and two 15- to 45-minute home-based training sessions per week to include aerobic, strength, flexibility, and balance training for 6 months. The ultimate goal is to accumulate 150 minutes of walking per week between center and home-based sessions.

Cognitive Training

The Cognitive Training (CT) intervention was developed to improve consciously-controlled memory processing or recollection of episodic memory information. Sessions were center-based, conducted via computer, carried out with small groups, and monitored by skilled trainers. Training consisted of four consecutive 10-12 min sessions per day, administered two times per week for two months, which then tapered to one time per week for two additional months. For each session, participants studied a list of 30 words, followed by a recognition test consisting of the 30 studied words and 30 new words with each new word repeated once, and asked to respond “yes” to study words and “no” to the new items both times they occurred.

Cognitive Training (CT): Two 1-hour sessions per week for the first two months and then one 1-hour session per week for months 3-6.

Combined Intervention

The Combined Intervention (PACT) was designed so that participants received both cognitive and physical activity training on the same day. To avoid the potential impact of physical fatigue on cognitive training, the cognitive treatment was delivered prior to the physical activity treatment. It included both the PA and CT interventions.

Physical Activity Training (PAT): Two 1-hour center and two 15- to 45-minute home-based training sessions per week to include aerobic, strength, flexibility, and balance training for 6 months. The ultimate goal is to accumulate 150 minutes of walking per week between center and home-based sessions.

Cognitive Training (CT): Two 1-hour sessions per week for the first two months and then one 1-hour session per week for months 3-6.

Healthy Aging

The Healthy Aging Education control intervention consisted of weekly lectures based on health education and was based on a program developed by the Lifestyle Interventions and Independence for Elders pilot trial [Rejeski, 2005; Lifestyle Interventions and Independence for Elders, 2006]. Topics such as medications, foot care, traveling and nutrition were covered. The purpose of the intervention was to provide contact time with participants.

Healthy Aging Education (HAE): One 1-hour lecture each week for 3 months, then monthly.


Participant Flow:   Overall Study
    Physical Activity Training   Cognitive Training   Combined Intervention   Healthy Aging
STARTED   18   18   19   18 
COMPLETED   16   16   18   17 
NOT COMPLETED   2   2   1   1 
Withdrawal by Subject                2                2                1                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Physical Activity Training

The Physical Activity Training ((PAT) intervention consisted of center-based and home-based sessions comprised of aerobic, strength, flexibility, and balance training with a targeted duration of 150 minutes/week. It included two center and two home-based training sessions per week for four months. Its primary focus was walking with the explicit intent of improving cardiovascular fitness. Other forms of endurance activity (e.g., stationary cycling) were used when regular walking was contraindicated for medical or behavioral reasons. Center-based physical activity sessions were supplemented with additional tailored home-based walking sessions at 1-2 per week during the first month.

Physical Activity Training (PAT): Two 1-hour center and two 15- to 45-minute home-based training sessions per week to include aerobic, strength, flexibility, and balance training for 6 months. The ultimate goal is to accumulate 150 minutes of walking per week between center and home-based sessions.

Cognitive Training

The Cognitive Training (CT) intervention was developed to improve consciously-controlled memory processing or recollection of episodic memory information. Sessions were center-based, conducted via computer, carried out with small groups, and monitored by skilled trainers. Training consisted of four consecutive 10-12 min sessions per day, administered two times per week for two months, which then tapered to one time per week for two additional months. For each session, participants studied a list of 30 words, followed by a recognition test consisting of the 30 studied words and 30 new words with each new word repeated once, and asked to respond “yes” to study words and “no” to the new items both times they occurred.

Cognitive Training (CT): Two 1-hour sessions per week for the first two months and then one 1-hour session per week for months 3-6.

Combined Intervention

The Combined Intervention (PACT) was designed so that participants received both cognitive and physical activity training on the same day. To avoid the potential impact of physical fatigue on cognitive training, the cognitive treatment was delivered prior to the physical activity treatment. It included both the PA and CT interventions.

Physical Activity Training (PAT): Two 1-hour center and two 15- to 45-minute home-based training sessions per week to include aerobic, strength, flexibility, and balance training for 6 months. The ultimate goal is to accumulate 150 minutes of walking per week between center and home-based sessions.

Cognitive Training (CT): Two 1-hour sessions per week for the first two months and then one 1-hour session per week for months 3-6.

Healthy Aging

The Healthy Aging Education control intervention consisted of weekly lectures based on health education and was based on a program developed by the Lifestyle Interventions and Independence for Elders pilot trial [Rejeski, 2005; LIFE, 2006]. Topics such as medications, foot care, traveling and nutrition were covered. The purpose of the intervention was to provide contact time with participants.

Healthy Aging Education (HAE): One 1-hour lecture each week for 3 months, then monthly.

Total Total of all reporting groups

Baseline Measures
   Physical Activity Training   Cognitive Training   Combined Intervention   Healthy Aging   Total 
Overall Participants Analyzed 
[Units: Participants]
 18   18   19   18   73 
Age 
[Units: Years]
Mean (Standard Deviation)
 77.5  (4.8)   76.0  (5.2)   76.9  (4.0)   75.4  (4.8)   76.4  (4.7) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      10  55.6%      8  44.4%      12  63.2%      7  38.9%      37  50.7% 
Male      8  44.4%      10  55.6%      7  36.8%      11  61.1%      36  49.3% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
         
African-American   1   1   4   1   7 
Caucasian   17   17   15   17   66 
Region of Enrollment 
[Units: Participants]
Count of Participants
         
United States   18   18   19   18   73 
400 meter walk time 
[Units: Seconds]
Mean (Standard Deviation)
 360  (48)   331  (50)   347  (56)   331  (66)   342  (55) 
Modified MiniMental State Exam Score [1] 
[Units: Points]
Mean (Standard Deviation)
 94.6  (3.9)   95.6  (3.4)   94.6  (4.3)   94.3  (2.4)   94.8  (3.5) 
[1] The Modified Mini Mental State Exam (3MS) Memory Functioning questionnaire asks the participant to rate on a scale of 1 (always) to 7 (never) how often remembering something presents a problem. In order to participate, subjects had to score at least an 88 or greater if their education level is greater than 8 years and if education level was 0-8 years, scores had to be at least an 80 or higher. The possible scores range from 0 to 100, with higher scores reflecting better global cognitive functioning.


  Outcome Measures
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1.  Primary:   Composite Cognitive Function in Z-scores (i.e. Which Convert Raw Data to Standard Deviation (SD) Units). This Composite is Formed by Averaging the Z-scores From Individual Tests.   [ Time Frame: Changes from baseline at 4 months in z-scores. ]

2.  Secondary:   Change in Executive Function: Z-score Formed by Averaging the Individual Z-scores From the Five Tests Listed Below.   [ Time Frame: Baseline to 4 months ]

3.  Secondary:   Composite Episodic Memory   [ Time Frame: Change a 4 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
While large enough to meet its objectives, our pilot trial involved a modest sample size and short follow-up.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Mark Espeland, PhD
Organization: Wake Forest School of Medicine
phone: 336-761-2826 ext 336
e-mail: mespelan@wakehealth.edu


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT00688155     History of Changes
Other Study ID Numbers: IA0133
1R01AG029285-01 ( U.S. NIH Grant/Contract )
First Submitted: May 29, 2008
First Posted: June 2, 2008
Results First Submitted: May 25, 2017
Results First Posted: December 7, 2017
Last Update Posted: December 7, 2017