Aortic Valve Stenosis
Conditions
Keywords
Transcatheter Aortic Valve Replacement, Exercise, Frailty, Functional Outcomes, Cognitive Behavioral Intervention
Brief summary
Transcatheter aortic valve replacement (TAVR) is a minimally invasive procedure for older adults with severe symptomatic aortic stenosis who are considered high risk for surgical aortic valve replacement. Despite symptomatic and survival benefits, many patients experience functional decline after TAVR. This pilot study aims to test the feasibility of a home-based exercise intervention targeting endurance, strength, and balance as well as cognitive behavioral intervention to improve physical functioning and disability after TAVR.
Detailed description
We hypothesize that a home-based exercise program with cognitive behavioral intervention is more effective than home-based exercise alone; home-based exercise program with and without cognitive behavioral intervention is more effective than attention control educational intervention in preventing decline in physical function and disability after TAVR.
Interventions
BEHAVIORALExercise
Exercises will target balance, flexibility, strength, and endurance (source: https://go4life.nia.nih.gov/). Home visits will take place twice a week for week 1 and 2; once a week for week 3 and 4; every other week for week for week 5 through week 8. Participants are instructed to do prescribed exercises for 30 minutes daily. The duration of this intervention is about 40 mins.
BEHAVIORALCognitive behavioral interventions
The following cognitive-behavioral strategies will be employed: 1) enhance positive beliefs about exercise through discussion of benefits of exercise; 2) discussion of barriers to exercise; 3) individualized goal setting and self-monitoring progress using exercise calendar; 4) develop a detailed exercise plan on how, what, when, and where to conduct exercise; 5) $10 rewards for exercising ≥30 mins per day for ≥5 of 7 days. The duration of this intervention is about 20 mins.
BEHAVIORALAttention control education program
A health care professional will call the participant weekly for a period of 8 weeks to teach general tips about exercise and diet (source: https://go4life.nia.nih.gov/). No recommendations for a specific exercise program will be made, except for walking 30 minutes daily or as tolerated. Each telephone session will cover 4 exercise tips and 4 healthy eating tips. The duration of the intervention is about 30 minutes.
Sponsors
Hebrew SeniorLife
National Institute on Aging (NIA)
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 65 years * Underwent transcatheter aortic valve replacement * Lives within 20-mile radius of the recruiting site * Plan to be discharged home * Able to provide informed consent
Exclusion criteria
* Stroke or any other medical disease that precludes participation in the exercise program * Severe cognitive impairment (Mini-Mental State Examination \< 15) * Current enrollment in another clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Late-Life Function and Disability Instrument (LLFDI) Score | At baseline and week 8 | The LLFDI is a validated patient-reported outcome questionnaire that measures both functional limitations (inability to perform physical tasks - Activity Limitation Domain score, range: 0-100) and disability (inability to perform major life tasks and social roles - Participation Restriction Domain score, range: 0-100). For both scales, higher values indicate better function (lower limitation or lower disability). Two domain scores are analyzed separately. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Short Physical Performance Battery (SPPB) Summary Score | At baseline and week 8 | The summary score is calculated based on chair stands, walking speed, and standing balance (range: 0-12). Higher scores indicate better physical performance. |
| Change in the 2-Minute Walk Distance (Feet) | At baseline and week 8 | The 2-minute walk distance measures endurance. A longer distance indicates better endurance. |
| Change in Dominant Hand Grip Strength (kg) | At baseline and week 8 | Dominant hand grip strength measures upper extremity strength. |
| Number of Participants Who Experienced Adverse Events | At week 8 | Number of participants who experience any adverse events and serious adverse events |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Mini-Mental State Examination (MMSE) Score | At baseline and week 8 | MMSE is an instrument that assesses general cognitive function (range: 0 to 30). Higher scores indicate better cognitive function. |
| Change in New York Heart Association (NYHA) Functional Class | At baseline and week 8 | NYHA assesses the extent of physical activity limitation due to heart failure. It ranges from 1 (ordinary physical activity does not cause symptoms) to 4 (symptoms occur at rest). |
| Change in the Self-Efficacy Scale for Exercise (SEE) | At baseline and week 8 | The SEE scale measures self-efficacy about exercise (range: 0-90). Higher values indicate higher self efficacy. |
| Change in the Outcome Expectation Scale for Exercise (OEE) | At baseline and week 8 | The OEE scale measures outcome expectation about exercise (range: 9-45). Higher scores indicate higher expectation. |
| Adherence to the Home-based Exercise Program | At week 8 | The proportion of days with completed daily task during the entire study period will be measured. |
Countries
United States
Participant flow
Recruitment details
Between August 2017 and February 2020, 64 patients were enrolled from the Beth Israel Deaconess Medical Center and the Brigham and Women's Hospital in Boston, MA.
Pre-assignment details
10 participants were disenrolled due to medical complications (n=5), rehabilitation facility discharge (n=2), and unavailability of the research team for assessment (n=3).
Participants by arm
| Arm | Count |
|---|---|
| Exercise & Cognitive Behavioral Int. A physical therapist will make home visits, beginning within 1 week of discharge, to deliver an individualized exercise program and cognitive behavioral interventions.
Exercise: Exercises will target balance, flexibility, strength, and endurance (source: https://go4life.nia.nih.gov/). Home visits will take place twice a week for week 1 and 2; once a week for week 3 and 4; every other week for week for week 5 through week 8. Participants are instructed to do prescribed exercises for 30 minutes daily. The duration of this intervention is about 40 mins.
Cognitive behavioral interventions: The following cognitive-behavioral strategies will be employed: 1) enhance positive beliefs about exercise through discussion of benefits of exercise; 2) discussion of barriers to exercise; 3) individualized goal setting and self-monitoring progress using exercise calendar; 4) develop a detailed exercise plan on how, what, when, and where to conduct exercise; 5) $10 rewards for exercising ≥30 mins per day for ≥5 of 7 days. The duration of this intervention is about 20 mins. | 18 |
| Exercise Alone A physical therapist will make home visits, beginning within 1 week of discharge, to deliver an individualized exercise program, without cognitive behavioral interventions.
Exercise: Exercises will target balance, flexibility, strength, and endurance (source: https://go4life.nia.nih.gov/). Home visits will take place twice a week for week 1 and 2; once a week for week 3 and 4; every other week for week for week 5 through week 8. Participants are instructed to do prescribed exercises for 30 minutes daily. The duration of this intervention is about 40 mins. | 15 |
| Attention Control Education Program Participants will receive telephone-based education sessions from a study health professional.
Attention control education program: A health care professional will call the participant weekly for a period of 8 weeks to teach general tips about exercise and diet (source: https://go4life.nia.nih.gov/). No recommendations for a specific exercise program will be made, except for walking 30 minutes daily or as tolerated. Each telephone session will cover 4 exercise tips and 4 healthy eating tips. The duration of the intervention is about 30 minutes. | 18 |
| Total | 51 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 2 | 2 |
| Overall Study | Post-Randomization Exclusion | 0 | 2 | 1 |
Baseline characteristics
| Characteristic | Exercise & Cognitive Behavioral Int. | Total | Attention Control Education Program | Exercise Alone |
|---|---|---|---|---|
| Activities of daily living dependence | 1 Participants | 4 Participants | 1 Participants | 2 Participants |
| Age, Continuous | 85.1 years STANDARD_DEVIATION 9.1 | 84.2 years STANDARD_DEVIATION 7.6 | 82.8 years STANDARD_DEVIATION 8 | 84.9 years STANDARD_DEVIATION 5.1 |
| Aortic valve area | 0.79 cm^2 STANDARD_DEVIATION 0.21 | 0.80 cm^2 STANDARD_DEVIATION 0.2 | 0.80 cm^2 STANDARD_DEVIATION 0.2 | 0.80 cm^2 STANDARD_DEVIATION 0.22 |
| At risk of malnutrition | 8 Participants | 18 Participants | 6 Participants | 4 Participants |
| Body mass index | 27.5 kg/m2 STANDARD_DEVIATION 6.4 | 28.7 kg/m2 STANDARD_DEVIATION 6 | 30.6 kg/m2 STANDARD_DEVIATION 6.3 | 27.9 kg/m2 STANDARD_DEVIATION 4.8 |
| Gait speed | 0.73 meter/second STANDARD_DEVIATION 0.29 | 0.65 meter/second STANDARD_DEVIATION 0.26 | 0.58 meter/second STANDARD_DEVIATION 0.23 | 0.65 meter/second STANDARD_DEVIATION 0.25 |
| Instrumental activities of daily living dependence | 6 Participants | 22 Participants | 9 Participants | 7 Participants |
| Left ventricular ejection fraction | 60.6 % STANDARD_DEVIATION 9.4 | 58.0 % STANDARD_DEVIATION 11.6 | 56.1 % STANDARD_DEVIATION 15.6 | 57.0 % STANDARD_DEVIATION 8.1 |
| Mini-Mental State Examination score | 25.8 units on a scale STANDARD_DEVIATION 3 | 25.7 units on a scale STANDARD_DEVIATION 3.3 | 25.4 units on a scale STANDARD_DEVIATION 4 | 25.8 units on a scale STANDARD_DEVIATION 3 |
| New York Heart Association Class 3-4 | 8 Participants | 23 Participants | 6 Participants | 9 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 18 Participants | 50 Participants | 17 Participants | 15 Participants |
| Region of Enrollment United States | 18 participants | 51 participants | 18 participants | 15 participants |
| Sex: Female, Male Female | 9 Participants | 19 Participants | 9 Participants | 1 Participants |
| Sex: Female, Male Male | 9 Participants | 32 Participants | 9 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 15 | 0 / 18 |
| other Total, other adverse events | 12 / 18 | 8 / 15 | 8 / 18 |
| serious Total, serious adverse events | 1 / 18 | 2 / 15 | 1 / 18 |
Outcome results
Primary
Change in the Late-Life Function and Disability Instrument (LLFDI) Score
The LLFDI is a validated patient-reported outcome questionnaire that measures both functional limitations (inability to perform physical tasks - Activity Limitation Domain score, range: 0-100) and disability (inability to perform major life tasks and social roles - Participation Restriction Domain score, range: 0-100). For both scales, higher values indicate better function (lower limitation or lower disability). Two domain scores are analyzed separately.
Time frame: At baseline and week 8
Population: The LLFDI Computer Adaptive Test software for Windows could not be run after the Windows operating system upgrade during our study period. LLFDI scores were available for 36 participants at baseline and 10 participants at 8 weeks. Therefore, we were unable to analyze the LLFDI score change. Instead, we measured a disability score (count of 22 daily activities and physical tasks that a person cannot perform without another person's help) post-hoc (see post-hoc outcome measure).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Exercise & Cognitive Behavioral Int. | Change in the Late-Life Function and Disability Instrument (LLFDI) Score | Activity Limitation Domain - Baseline | 53.2 units on a scale | Standard Deviation 7.2 |
| Exercise & Cognitive Behavioral Int. | Change in the Late-Life Function and Disability Instrument (LLFDI) Score | Activity Limitation Domain - Week 8 | 58.9 units on a scale | Standard Deviation 9.5 |
| Exercise & Cognitive Behavioral Int. | Change in the Late-Life Function and Disability Instrument (LLFDI) Score | Participation Restriction Domain - Baseline | 48.7 units on a scale | Standard Deviation 8.1 |
| Exercise & Cognitive Behavioral Int. | Change in the Late-Life Function and Disability Instrument (LLFDI) Score | Participation Restriction Domain - Week 8 | 49.1 units on a scale | Standard Deviation 12 |
| Exercise Alone | Change in the Late-Life Function and Disability Instrument (LLFDI) Score | Participation Restriction Domain - Week 8 | 35.3 units on a scale | Standard Deviation 1.4 |
| Exercise Alone | Change in the Late-Life Function and Disability Instrument (LLFDI) Score | Activity Limitation Domain - Baseline | 52.0 units on a scale | Standard Deviation 8.6 |
| Exercise Alone | Change in the Late-Life Function and Disability Instrument (LLFDI) Score | Participation Restriction Domain - Baseline | 47.2 units on a scale | Standard Deviation 8.6 |
| Exercise Alone | Change in the Late-Life Function and Disability Instrument (LLFDI) Score | Activity Limitation Domain - Week 8 | 43 units on a scale | Standard Deviation 2.8 |
| Attention Control Education Program | Change in the Late-Life Function and Disability Instrument (LLFDI) Score | Participation Restriction Domain - Week 8 | 47.5 units on a scale | Standard Deviation 13.7 |
| Attention Control Education Program | Change in the Late-Life Function and Disability Instrument (LLFDI) Score | Activity Limitation Domain - Week 8 | 54.4 units on a scale | Standard Deviation 6.4 |
| Attention Control Education Program | Change in the Late-Life Function and Disability Instrument (LLFDI) Score | Participation Restriction Domain - Baseline | 47.3 units on a scale | Standard Deviation 5.8 |
| Attention Control Education Program | Change in the Late-Life Function and Disability Instrument (LLFDI) Score | Activity Limitation Domain - Baseline | 52.9 units on a scale | Standard Deviation 5.9 |
Secondary
Change in Dominant Hand Grip Strength (kg)
Dominant hand grip strength measures upper extremity strength.
Time frame: At baseline and week 8
Population: Participants with available data were analyzed.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Exercise & Cognitive Behavioral Int. | Change in Dominant Hand Grip Strength (kg) | Baseline | 21.8 kg | Standard Error 2.9 |
| Exercise & Cognitive Behavioral Int. | Change in Dominant Hand Grip Strength (kg) | Week 8 | 23.0 kg | Standard Error 3.1 |
| Exercise Alone | Change in Dominant Hand Grip Strength (kg) | Baseline | 23.7 kg | Standard Error 3.4 |
| Exercise Alone | Change in Dominant Hand Grip Strength (kg) | Week 8 | 22.8 kg | Standard Error 3.9 |
| Attention Control Education Program | Change in Dominant Hand Grip Strength (kg) | Baseline | 19.5 kg | Standard Error 2.8 |
| Attention Control Education Program | Change in Dominant Hand Grip Strength (kg) | Week 8 | 24.1 kg | Standard Error 3.5 |
Secondary
Change in the 2-Minute Walk Distance (Feet)
The 2-minute walk distance measures endurance. A longer distance indicates better endurance.
Time frame: At baseline and week 8
Population: Participants with available data were analyzed.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Exercise & Cognitive Behavioral Int. | Change in the 2-Minute Walk Distance (Feet) | Baseline | 313.9 feet | Standard Error 27.2 |
| Exercise & Cognitive Behavioral Int. | Change in the 2-Minute Walk Distance (Feet) | Week 8 | 333.0 feet | Standard Error 25.4 |
| Exercise Alone | Change in the 2-Minute Walk Distance (Feet) | Baseline | 279.0 feet | Standard Error 31.1 |
| Exercise Alone | Change in the 2-Minute Walk Distance (Feet) | Week 8 | 357.4 feet | Standard Error 29.5 |
| Attention Control Education Program | Change in the 2-Minute Walk Distance (Feet) | Baseline | 244.6 feet | Standard Error 32.8 |
| Attention Control Education Program | Change in the 2-Minute Walk Distance (Feet) | Week 8 | 282.8 feet | Standard Error 29.4 |
Secondary
Change in the Short Physical Performance Battery (SPPB) Summary Score
The summary score is calculated based on chair stands, walking speed, and standing balance (range: 0-12). Higher scores indicate better physical performance.
Time frame: At baseline and week 8
Population: Participants with available data were analyzed.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Exercise & Cognitive Behavioral Int. | Change in the Short Physical Performance Battery (SPPB) Summary Score | Baseline | 5.9 units on a scale | Standard Error 0.7 |
| Exercise & Cognitive Behavioral Int. | Change in the Short Physical Performance Battery (SPPB) Summary Score | Week 8 | 9.7 units on a scale | Standard Error 0.8 |
| Exercise Alone | Change in the Short Physical Performance Battery (SPPB) Summary Score | Baseline | 4.5 units on a scale | Standard Error 0.8 |
| Exercise Alone | Change in the Short Physical Performance Battery (SPPB) Summary Score | Week 8 | 9.3 units on a scale | Standard Error 0.9 |
| Attention Control Education Program | Change in the Short Physical Performance Battery (SPPB) Summary Score | Baseline | 5.3 units on a scale | Standard Error 0.7 |
| Attention Control Education Program | Change in the Short Physical Performance Battery (SPPB) Summary Score | Week 8 | 6.5 units on a scale | Standard Error 0.8 |
Secondary
Number of Participants Who Experienced Adverse Events
Number of participants who experience any adverse events and serious adverse events
Time frame: At week 8
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Exercise & Cognitive Behavioral Int. | Number of Participants Who Experienced Adverse Events | Any adverse event | 12 Participants |
| Exercise & Cognitive Behavioral Int. | Number of Participants Who Experienced Adverse Events | Any serious adverse event | 1 Participants |
| Exercise Alone | Number of Participants Who Experienced Adverse Events | Any adverse event | 8 Participants |
| Exercise Alone | Number of Participants Who Experienced Adverse Events | Any serious adverse event | 2 Participants |
| Attention Control Education Program | Number of Participants Who Experienced Adverse Events | Any adverse event | 8 Participants |
| Attention Control Education Program | Number of Participants Who Experienced Adverse Events | Any serious adverse event | 1 Participants |
Other Pre-specified
Adherence to the Home-based Exercise Program
The proportion of days with completed daily task during the entire study period will be measured.
Time frame: At week 8
Other Pre-specified
Change in Mini-Mental State Examination (MMSE) Score
MMSE is an instrument that assesses general cognitive function (range: 0 to 30). Higher scores indicate better cognitive function.
Time frame: At baseline and week 8
Population: Participants with available data were analyzed.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Exercise & Cognitive Behavioral Int. | Change in Mini-Mental State Examination (MMSE) Score | Baseline | 25.8 units on a scale | Standard Error 0.8 |
| Exercise & Cognitive Behavioral Int. | Change in Mini-Mental State Examination (MMSE) Score | Week 8 | 26.7 units on a scale | Standard Error 0.9 |
| Exercise Alone | Change in Mini-Mental State Examination (MMSE) Score | Baseline | 25.8 units on a scale | Standard Error 0.8 |
| Exercise Alone | Change in Mini-Mental State Examination (MMSE) Score | Week 8 | 28.4 units on a scale | Standard Error 1.1 |
| Attention Control Education Program | Change in Mini-Mental State Examination (MMSE) Score | Baseline | 25.4 units on a scale | Standard Error 0.8 |
| Attention Control Education Program | Change in Mini-Mental State Examination (MMSE) Score | Week 8 | 27.7 units on a scale | Standard Error 0.9 |
Other Pre-specified
Change in New York Heart Association (NYHA) Functional Class
NYHA assesses the extent of physical activity limitation due to heart failure. It ranges from 1 (ordinary physical activity does not cause symptoms) to 4 (symptoms occur at rest).
Time frame: At baseline and week 8
Population: Participants with available data were analyzed.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Exercise & Cognitive Behavioral Int. | Change in New York Heart Association (NYHA) Functional Class | Baseline | 2.4 units on a scale | Standard Error 0.2 |
| Exercise & Cognitive Behavioral Int. | Change in New York Heart Association (NYHA) Functional Class | Week 8 | 1.7 units on a scale | Standard Error 0.2 |
| Exercise Alone | Change in New York Heart Association (NYHA) Functional Class | Baseline | 2.6 units on a scale | Standard Error 0.2 |
| Exercise Alone | Change in New York Heart Association (NYHA) Functional Class | Week 8 | 1.8 units on a scale | Standard Error 0.2 |
| Attention Control Education Program | Change in New York Heart Association (NYHA) Functional Class | Baseline | 2.2 units on a scale | Standard Error 0.2 |
| Attention Control Education Program | Change in New York Heart Association (NYHA) Functional Class | Week 8 | 1.6 units on a scale | Standard Error 0.2 |
Other Pre-specified
Change in the Outcome Expectation Scale for Exercise (OEE)
The OEE scale measures outcome expectation about exercise (range: 9-45). Higher scores indicate higher expectation.
Time frame: At baseline and week 8
Population: Participants with available data were analyzed.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Exercise & Cognitive Behavioral Int. | Change in the Outcome Expectation Scale for Exercise (OEE) | Baseline | 19.0 units on a scale | Standard Error 1.3 |
| Exercise & Cognitive Behavioral Int. | Change in the Outcome Expectation Scale for Exercise (OEE) | Week 8 | 16.8 units on a scale | Standard Error 1.5 |
| Exercise Alone | Change in the Outcome Expectation Scale for Exercise (OEE) | Baseline | 19.2 units on a scale | Standard Error 1.5 |
| Exercise Alone | Change in the Outcome Expectation Scale for Exercise (OEE) | Week 8 | 16.6 units on a scale | Standard Error 1.9 |
| Attention Control Education Program | Change in the Outcome Expectation Scale for Exercise (OEE) | Baseline | 18.2 units on a scale | Standard Error 1.4 |
| Attention Control Education Program | Change in the Outcome Expectation Scale for Exercise (OEE) | Week 8 | 15.7 units on a scale | Standard Error 1.6 |
Other Pre-specified
Change in the Self-Efficacy Scale for Exercise (SEE)
The SEE scale measures self-efficacy about exercise (range: 0-90). Higher values indicate higher self efficacy.
Time frame: At baseline and week 8
Population: Participants with available data were analyzed.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Exercise & Cognitive Behavioral Int. | Change in the Self-Efficacy Scale for Exercise (SEE) | Baseline | 50.5 units on a scale | Standard Error 5.8 |
| Exercise & Cognitive Behavioral Int. | Change in the Self-Efficacy Scale for Exercise (SEE) | Week 8 | 66.2 units on a scale | Standard Error 6.9 |
| Exercise Alone | Change in the Self-Efficacy Scale for Exercise (SEE) | Baseline | 54.5 units on a scale | Standard Error 6.2 |
| Exercise Alone | Change in the Self-Efficacy Scale for Exercise (SEE) | Week 8 | 59.6 units on a scale | Standard Error 8.7 |
| Attention Control Education Program | Change in the Self-Efficacy Scale for Exercise (SEE) | Baseline | 53.6 units on a scale | Standard Error 5.7 |
| Attention Control Education Program | Change in the Self-Efficacy Scale for Exercise (SEE) | Week 8 | 51.1 units on a scale | Standard Error 6.8 |
Post Hoc
Disability Score
The disability score measures the count of 22 daily activities and physical tasks that a person cannot perform without another person's help. It ranges from 0 to 22. Higher values indicate severe disability. Its correlation with LLFDI was -0.76 against the Activity Limitation Domain score and -0.65 against the Participation Restriction Domain score.
Time frame: At baseline and week 8
Population: Participants with available data were analyzed.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Exercise & Cognitive Behavioral Int. | Disability Score | Week 8 | 2.1 units on a scale | Standard Error 0.4 |
| Exercise & Cognitive Behavioral Int. | Disability Score | Baseline | 2.8 units on a scale | Standard Error 0.4 |
| Exercise Alone | Disability Score | Baseline | 3.1 units on a scale | Standard Error 0.5 |
| Exercise Alone | Disability Score | Week 8 | 3.4 units on a scale | Standard Error 0.5 |
| Attention Control Education Program | Disability Score | Baseline | 3.8 units on a scale | Standard Error 0.5 |
| Attention Control Education Program | Disability Score | Week 8 | 4.5 units on a scale | Standard Error 0.5 |