Trial Outcomes & Findings for An Intervention to Improve Function in Severe Cardiopulmonary Illness (NCT NCT00467298)

Results Overview

6MWT-Six Minute Walk Test

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

90 participants

Primary outcome timeframe

6 months

Results posted on

2018-04-02

Participant Flow

Participant milestones

Participant milestones
Measure	Self-management Novel intensive self-management education and exercise program of four weeks Exercise adherence: The exercise program includes endurance and strength training and warm-up and cool-down strategies. Emphasis is placed upon implementing and adhering to the exercise program at home following intervention completion. Self-management- prevention of illness: Instruction is provided regarding key elements of managing heart failure and COPD with emphasis upon individual adaptations to prevent exacerbations, unscheduled provider visits, and hospital admissions as well as promotion of daily activity. Self-management of illness: This component of the intervention stresses the use of an action plan that is implemented to c-manage bouts of mild illness and to identify symptoms of more serious illness, including appropriate actions.	Usual Care Usual care- cardiac or pulmonary rehabilitation exercise program of 8 weeks duration
Overall Study STARTED	46	44
Overall Study COMPLETED	42	38
Overall Study NOT COMPLETED	4	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

An Intervention to Improve Function in Severe Cardiopulmonary Illness

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Self-management n=46 Participants Novel intensive self-management education and exercise program of four weeks Exercise adherence: The exercise program includes endurance and strength training and warm-up and cool-down strategies. Emphasis is placed upon implementing and adhering to the exercise program at home following intervention completion. Self-management- prevention of illness: Instruction is provided regarding key elements of managing heart failure and COPD with emphasis upon individual adaptations to prevent exacerbations, unscheduled provider visits, and hospital admissions as well as promotion of daily activity. Self-management of illness: This component of the intervention stresses the use of an action plan that is implemented to c-manage bouts of mild illness and to identify symptoms of more serious illness, including appropriate actions.	Usual Care n=44 Participants Usual care- cardiac or pulmonary rehabilitation exercise program of 8 weeks duration	Total n=90 Participants Total of all reporting groups
Age, Continuous	65.6 years STANDARD_DEVIATION 10 • n=99 Participants	66.4 years STANDARD_DEVIATION 8 • n=107 Participants	66 years STANDARD_DEVIATION 9 • n=206 Participants
Sex: Female, Male Female	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Sex: Female, Male Male	46 Participants n=99 Participants	44 Participants n=107 Participants	90 Participants n=206 Participants

PRIMARY outcome

Timeframe: 6 months

6MWT-Six Minute Walk Test

Outcome measures

Outcome measures
Measure	Self-management n=46 Participants Novel intensive self-management education and exercise program of four weeks Exercise adherence: The exercise program includes endurance and strength training and warm-up and cool-down strategies. Emphasis is placed upon implementing and adhering to the exercise program at home following intervention completion. Self-management- prevention of illness: Instruction is provided regarding key elements of managing heart failure and COPD with emphasis upon individual adaptations to prevent exacerbations, unscheduled provider visits, and hospital admissions as well as promotion of daily activity. Self-management of illness: This component of the intervention stresses the use of an action plan that is implemented to c-manage bouts of mild illness and to identify symptoms of more serious illness, including appropriate actions.	Usual Care n=44 Participants Usual care- cardiac or pulmonary rehabilitation exercise program of 8 weeks duration
Function Capability	349 meters Standard Deviation 146	338 meters Standard Deviation 122

SECONDARY outcome

Timeframe: 6 months

Population: These are not change scores.

SF-36 PCS. Scale range 0-100, higher scores reflect higher quality of life. PCS=Physical Composite Score. These are not change scores.

Outcome measures

Outcome measures
Measure	Self-management n=46 Participants Novel intensive self-management education and exercise program of four weeks Exercise adherence: The exercise program includes endurance and strength training and warm-up and cool-down strategies. Emphasis is placed upon implementing and adhering to the exercise program at home following intervention completion. Self-management- prevention of illness: Instruction is provided regarding key elements of managing heart failure and COPD with emphasis upon individual adaptations to prevent exacerbations, unscheduled provider visits, and hospital admissions as well as promotion of daily activity. Self-management of illness: This component of the intervention stresses the use of an action plan that is implemented to c-manage bouts of mild illness and to identify symptoms of more serious illness, including appropriate actions.	Usual Care n=44 Participants Usual care- cardiac or pulmonary rehabilitation exercise program of 8 weeks duration
Quality of Life	31 units on a scale Standard Deviation 8	38 units on a scale Standard Deviation 13

Adverse Events

Self-management

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

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

Adverse event data not reported

Additional Information

Cynthia M. Dougherty

VA Puget Sound Health Care System-Seattle

Phone: 206 764 2205

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place