Trial Outcomes & Findings for Strength Training for Skeletal Muscle Adaptation After Stroke (NCT NCT00827827)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

38 participants

Primary outcome timeframe

Baseline, 3 months

Results posted on

2018-07-09

Participant Flow

Participant milestones

Participant milestones
Measure	Strength Training Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors. Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour.	Stretching Control Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables. Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises
Overall Study STARTED	22	16
Overall Study COMPLETED	14	16
Overall Study NOT COMPLETED	8	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Strength Training Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors. Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour.	Stretching Control Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables. Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises
Overall Study Lost to Follow-up	3	0
Overall Study Fall at home- hospitalization	1	0
Overall Study Another cerebrovascular accident (CVA)	1	0
Overall Study Gout	1	0
Overall Study Transportation issues	1	0
Overall Study Burned with water at home	1	0

Baseline Characteristics

Strength Training for Skeletal Muscle Adaptation After Stroke

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Strength Training n=22 Participants Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors. Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour.	Stretching Control n=16 Participants Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables. Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises	Total n=38 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=5 Participants	14 Participants n=7 Participants	33 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Age, Continuous	56.9 years STANDARD_DEVIATION 11.5 • n=5 Participants	55.2 years STANDARD_DEVIATION 8.7 • n=7 Participants	56.2 years STANDARD_DEVIATION 10.3 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	12 Participants n=7 Participants	28 Participants n=5 Participants
Region of Enrollment United States	22 participants n=5 Participants	16 participants n=7 Participants	38 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 3 months

Population: All participants for whom strength measurements were recorded at Baseline and 3 months

Outcome measures

Outcome measures
Measure	Strength Training n=14 Participants Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors. Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour.	Stretching Control n=16 Participants Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables. Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises
Change in 1-repetition Maximum (RM) Muscle Strength (Leg Press, Paretic Side)	126.1 lbs Standard Error 22.2	11.3 lbs Standard Error 14.6

PRIMARY outcome

Timeframe: Baseline, 3 months

Population: All participants for whom strength measurements were recorded at Baseline and 3 months

Outcome measures

Outcome measures
Measure	Strength Training n=14 Participants Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors. Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour.	Stretching Control n=16 Participants Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables. Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises
Change in 1-RM Muscle Strength (Leg Press, Non-Paretic Side)	93.2 lbs Standard Error 26.1	22.7 lbs Standard Error 16.4

PRIMARY outcome

Timeframe: Baseline, 3 Months

Population: All participants for whom strength measurements were recorded at Baseline and 3 months

Outcome measures

Outcome measures
Measure	Strength Training n=14 Participants Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors. Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour.	Stretching Control n=16 Participants Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables. Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises
Change in 1-RM Muscle Strength (Leg Extension, Paretic Side)	28.6 lbs Standard Error 4.3	3.4 lbs Standard Error 2.4

PRIMARY outcome

Timeframe: Baseline, 3 Months

Population: All participants for whom strength measurements were recorded at Baseline and 3 months

Outcome measures

Outcome measures
Measure	Strength Training n=13 Participants Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors. Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour.	Stretching Control n=16 Participants Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables. Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises
Change in 1-RM Muscle Strength (Leg Extension, Non-Paretic Side)	20.8 lbs Standard Error 0.4	0.4 lbs Standard Error 2.6

PRIMARY outcome

Timeframe: Baseline, 3 Months

Population: All participants for whom muscle endurance measurements were recorded at Baseline and 3 months

Tests how training impacts the total number of submaximal repetitions a participant can perform according to standardized cadence (at the same absolute level of resistance, pre and post).

Outcome measures

Outcome measures
Measure	Strength Training n=14 Participants Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors. Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour.	Stretching Control n=15 Participants Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables. Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises
Change in Leg Muscle Endurance (Paretic Side)	27.4 repetitions Standard Error 4.5	2.0 repetitions Standard Error 2.1

PRIMARY outcome

Timeframe: Baseline, 3 months

Population: All participants for whom muscle endurance measurements were recorded at Baseline and 3 months

Tests how training impacts the total number of submaximal repetitions a participant can perform according to standardized cadence (at the same absolute level of resistance, pre and post).

Outcome measures

Outcome measures
Measure	Strength Training n=14 Participants Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors. Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour.	Stretching Control n=15 Participants Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables. Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises
Change in Leg Muscle Endurance (Non-Paretic Side)	27.5 repetitions Standard Error 5.0	1.8 repetitions Standard Error 1.8

PRIMARY outcome

Timeframe: Baseline, 3 Months

Population: All participants for whom 6-minute walk distance was recorded at Baseline and 3 months

Outcome measures

Outcome measures
Measure	Strength Training n=13 Participants Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors. Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour.	Stretching Control n=16 Participants Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables. Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises
Change in 6-minute Walk Distance	132.3 feet Standard Error 48.3	-2.1 feet Standard Error 21.6

PRIMARY outcome

Timeframe: Baseline, 3 months

Population: All participants for whom 10 Meter walking Speed (Self-Selected) was recorded at Baseline and 3 months

Outcome measures

Outcome measures
Measure	Strength Training n=14 Participants Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors. Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour.	Stretching Control n=16 Participants Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables. Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises
Change in 10 Meter Walking Speed (Self-Selected)	0.16 meters/ second Standard Error 0.09	0.03 meters/ second Standard Error 0.06

PRIMARY outcome

Timeframe: Baseline, 3 Months

Population: All participants for whom 10 Meter walking Speed (Fastest-Safe) was recorded at Baseline and 3 months

Outcome measures

Outcome measures
Measure	Strength Training n=13 Participants Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors. Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour.	Stretching Control n=14 Participants Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables. Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises
Change in 10 Meter Walking Speed (Fastest)	0.24 meters/ second Standard Error 0.10	0.09 meters/ second Standard Error 0.08

PRIMARY outcome

Timeframe: Baseline, 3 Months

Population: All participants for whom Peak Aerobic Capacity was recorded during Graded Treadmill Test at Baseline and 3 months

Outcome measures

Outcome measures
Measure	Strength Training n=14 Participants Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors. Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour.	Stretching Control n=15 Participants Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables. Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises
Change in Peak Aerobic Capacity (VO2 Peak)	1.2 mls/kg/min Standard Error 0.6	-0.4 mls/kg/min Standard Error 0.5

PRIMARY outcome

Timeframe: Baseline, 3 months

Population: All participants for whom a Berg Score was recorded at Baseline and 3 months

This measure is a 14 item scale, with each item scored (0-4) and summed for a maximum score of 56 points. Range is 0-56 and higher values represent a better outcome.