Trial Outcomes & Findings for Water-based Activity to Enhance Recall in Veterans (NCT NCT02614092)

NCT ID: NCT02614092

Last Updated: 2024-04-17

Results Overview

Feasibility will be demonstrated through ratio of enrolled to completed participants

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 101 participants
• Primary outcome timeframe: Through Study Completion, an average of 8 months
• Results posted on: 2024-04-17

Participant Flow

After providing informed consent, enrolled participants were screened for eligibility. Only those enrolled participants who met all eligibility criteria were allowed to participate in the water-based activity + cognitive training intervention.

Participant milestones

Measure	Water Based Activity+ Cognitive Training This is an 8 month long two phase intervention. The first phase consists of 6 months of thrice weekly pool based physical activity occurring at the Palo Alto VA Health Care System. After completion of the 6 month long water based physical activity, participants transition to a ten session cognitive training program at the Palo Alto VA. The cognitive training classes are approximately two hours in length and will be spread over ten sessions across 4 weeks.
Overall Study STARTED	101
Overall Study Met All Eligibility Criteria	31
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	80

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Water-based Activity to Enhance Recall in Veterans

Baseline characteristics by cohort

Measure	Water Based Activity+ Cognitive Training n=31 Participants This is an 8 month long two phase intervention. The first phase consists of 6 months of thrice weekly pool based physical activity occurring at the Palo Alto VA Health Care System. After completion of the 6 month long water based physical activity, participants transition to a ten session cognitive training program at the Palo Alto VA. The cognitive training classes are approximately two hours in length and will be spread over ten sessions across 4 weeks.
Age, Continuous	68.3 years STANDARD_DEVIATION 7.9 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	26 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	21 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	31 Participants n=5 Participants

PRIMARY outcome

Timeframe: Through Study Completion, an average of 8 months

Feasibility will be demonstrated through ratio of enrolled to completed participants

Outcome measures

Measure

Water Based Activity+ Cognitive Training n=31 Participants This is an 8 month long two phase intervention. The first phase consists of 6 months of thrice weekly pool based physical activity occurring at the Palo Alto VA Health Care System. After completion of the 6 month long water based physical activity, participants transition to a ten session cognitive training program at the Palo Alto VA. The cognitive training classes are approximately two hours in length and will be spread over ten sessions across 4 weeks.

Retention and Recruitment Rates

21 Participants

SECONDARY outcome

Timeframe: Through Study Completion, an average of 8 months

Change From Baseline on the Delayed Recall of a Word List at 8 months

Outcome measures

Measure

Water Based Activity+ Cognitive Training n=31 Participants This is an 8 month long two phase intervention. The first phase consists of 6 months of thrice weekly pool based physical activity occurring at the Palo Alto VA Health Care System. After completion of the 6 month long water based physical activity, participants transition to a ten session cognitive training program at the Palo Alto VA. The cognitive training classes are approximately two hours in length and will be spread over ten sessions across 4 weeks.

Change in Delayed Recall of a Word List

3.94 Words Recalled Standard Deviation 3.94

SECONDARY outcome

Timeframe: Through Study Completion, an average of 8 months

Participant completion of study related measurements including pedometers, activity logs, cognitive training homework

Outcome measures

Measure

Water Based Activity+ Cognitive Training n=31 Participants This is an 8 month long two phase intervention. The first phase consists of 6 months of thrice weekly pool based physical activity occurring at the Palo Alto VA Health Care System. After completion of the 6 month long water based physical activity, participants transition to a ten session cognitive training program at the Palo Alto VA. The cognitive training classes are approximately two hours in length and will be spread over ten sessions across 4 weeks.

Participant Adherence to Protocol

63.5 percentage of weeks completed homework Interval 12.5 to 97.1

SECONDARY outcome

Timeframe: From time of consent until completion of Time 3 assessments, an average of 8 months

Number of reported serious and non-serious adverse events reported by participants who were eligible for study participation.

Outcome measures

Measure

Water Based Activity+ Cognitive Training n=31 Participants This is an 8 month long two phase intervention. The first phase consists of 6 months of thrice weekly pool based physical activity occurring at the Palo Alto VA Health Care System. After completion of the 6 month long water based physical activity, participants transition to a ten session cognitive training program at the Palo Alto VA. The cognitive training classes are approximately two hours in length and will be spread over ten sessions across 4 weeks.

Appropriateness of Inclusion and Exclusion Criteria

10 # of events

Adverse Events

Water Based Activity+ Cognitive Training

Serious events: 3 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Measure	Water Based Activity+ Cognitive Training n=31 participants at risk This is an 8 month long two phase intervention. The first phase consists of 6 months of thrice weekly pool based physical activity occurring at the Palo Alto VA Health Care System. After completion of the 6 month long water based physical activity, participants transition to a ten session cognitive training program at the Palo Alto VA. The cognitive training classes are approximately two hours in length and will be spread over ten sessions across 4 weeks.
Cardiac disorders Cardiac discomfort	3.2% 1/31 • Number of events 1 • AEs, SAEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 8 months The definition of AEs and SEs does not differ from the provided definition. AEs and SAEs were collected at each study visit.
Cardiac disorders CVA	3.2% 1/31 • Number of events 1 • AEs, SAEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 8 months The definition of AEs and SEs does not differ from the provided definition. AEs and SAEs were collected at each study visit.
Cardiac disorders Atrial Fibrillation	3.2% 1/31 • Number of events 1 • AEs, SAEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 8 months The definition of AEs and SEs does not differ from the provided definition. AEs and SAEs were collected at each study visit.

Other adverse events

Measure	Water Based Activity+ Cognitive Training n=31 participants at risk This is an 8 month long two phase intervention. The first phase consists of 6 months of thrice weekly pool based physical activity occurring at the Palo Alto VA Health Care System. After completion of the 6 month long water based physical activity, participants transition to a ten session cognitive training program at the Palo Alto VA. The cognitive training classes are approximately two hours in length and will be spread over ten sessions across 4 weeks.
Cardiac disorders High Blood Pressure	9.7% 3/31 • Number of events 5 • AEs, SAEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 8 months The definition of AEs and SEs does not differ from the provided definition. AEs and SAEs were collected at each study visit.
Cardiac disorders Low Blood Pressure	3.2% 1/31 • Number of events 1 • AEs, SAEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 8 months The definition of AEs and SEs does not differ from the provided definition. AEs and SAEs were collected at each study visit.
Injury, poisoning and procedural complications Fall	3.2% 1/31 • Number of events 2 • AEs, SAEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 8 months The definition of AEs and SEs does not differ from the provided definition. AEs and SAEs were collected at each study visit.
Musculoskeletal and connective tissue disorders Knee Pain	3.2% 1/31 • Number of events 1 • AEs, SAEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 8 months The definition of AEs and SEs does not differ from the provided definition. AEs and SAEs were collected at each study visit.

Additional Information

Dr. Kaci Fairchild

VISN 21 MIRECC, VA Palo Alto Health Care System

Phone: 6504935000

Email: jenniferkaci.fairchild@va.gov

Results disclosure agreements

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