Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00107068
Status:
COMPLETED
Last Update Posted:
2015-12-03
First Post:
2005-04-04
Brief Title:
Exercise Training and Walking Ability After Chronic Stroke
Sponsor:
University of Sydney
Organization:
University of Sydney
Study Overview
Official Title:
Does Aerobic or Resistance Exercise Training Improve Walking Ability in Chronic Stroke Patients
Status:
COMPLETED
Status Verified Date:
2015-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will investigate the efficacy of aerobic exercise and progressive resistance training PRT singularly and combined on changes in walking endurance for mildly-to-moderately affected chronic stroke patients Specifically we will determine the relative importance of training induced changes in muscle strength versus aerobic fitness on increases in gait velocity and 6-min walking distance and assess the concomitant functional and psychosocial impact of increased muscle strength aerobic fitness and improved gait This longitudinal study will be conducted as a double blinded factorial randomized controlled trial of exercise training for chronic stroke patients
Detailed Description:
The experimental hypotheses are
1 Participation in a 10-week exercise program consisting of aerobic resistance or combined aerobicresistance training will produce a 20 or greater increase of 6-min walking distance compared to controls
2 Aerobic fitness will increase equally in the combined aerobicresistance program and aerobic program alone greater than that in the resistance program only where effect is measured in terms of maximal and submaximal cardiorespiratory exercise performance
3 Lower limb muscle strength will increase equally in the combined aerobicresistance program and resistance program alone greater than the increase in strength for aerobic training where effect is measured in terms of measures of lower limb strength power and endurance
Research Plan Synopsis
To determine treatment efficacy a 2x2 factorial double-blinded randomized controlled trial will be conducted the two factors being aerobic training and PRT Forty-eight subjects will be randomly allocated to one of four groups comprising i aerobic exercise training AEROBIC n12 ii PRT RESISTANCE n12 iii combined aerobic training and PRT AEROBICRESISTANCE n12 or iv control CONTROLS n12 AEROBIC and RESISTANCE groups will also include a sham treatment for the other factor and the order of presentation of treatment versus sham will also be randomized within each exercise session All subjects will attend 3 times per week for 10 weeks Subjects will be recruited from various hospitals peer support groups and previous participants of an acute stroke research project that we are now conducting All will be screened by a medical practitioner for inclusion and exclusion criteria and then allocated to one of the four groups by the trial coordinator
Interventions
AEROBIC Training Group These subjects will undertake 30 min of leg cycling per exercise session Leg cycling will be performed at a pedaling cadence of 50 revmin in the seated posture using a standard seated cycle ergometer to elicit a target heart rate equivalent to 50 VO2peak - 70 VO2peak Subjects in this group will also undertake 30-min of sham resistance training consisting of stretching and calisthenics lacking any strength development characteristics Cycle ergometry will be used to develop aerobic fitness rather than fast walking because previous studies have shown that stroke patients do not have the capacity to walk at a sufficient pace to provide an adequate stimulus to the cardiovascular system
RESISTANCE Training Group These subjects will undertake 30 min of PRT per exercise session using pneumatic resistance equipment and free weights Standard PRT principles governing frequency volume duration and intensity of exercise known to provide maximal adaptation in both healthy and frail adults will be followed Legs will be trained unilaterally to maximize neural recruitment of the impaired side and prevent substitution of stronger muscles for weaker ones Subjects will perform 3 sets of 8 repetitions at 80 of the one repetition maximum with each muscle group Subjects in this group will also undertake 30-min of sham aerobic training consisting of motorized passive leg cycling
AEROBIC RESISTANCE Training Group Subjects in the AEROBICRESISTANCE training group will undertake 30 min of leg cycling exercise as described for the AEROBIC group in addition to 30 min of PRT as described for the RESISTANCE group per exercise session
CONTROL Group Subjects in this group will undertake 30-min of sham aerobic training consisting of motorized passive leg cycling and 30-min of sham resistance training consisting of stretching and calisthenics lacking any strength development characteristics per session
Outcomes
Primary outcome Subjects will undertake a 6 min walking test for maximum distance The 6-min test has been selected as our primary outcome because walking distance is an important criteria for community ambulation it avoids the problem of gait velocity being relevant only for short-distance ambulation and has a prior history of investigation in previous studies of low intensity aerobic and resistance training
Secondary outcomes
A Cardiorespiratory Fitness will be assessed from cardiorespiratory variables collected during i a maximal effort cycle test ii a multi stage submaximal exercise cycle test and iii a dual stage treadmill walking test performed on separate days
B Lower limb Muscular Strength and Endurance will be assessed from maximal muscle force maximal muscle power and muscle endurance using pneumatic resistance machines leg press knee extension and free weights hip abduction ankle dorsiflexion
C Mobility Variables
Temporal velocity step time single support double support and spatial step length and stride length variables will be collected using a gait analysis system Balance in standing and coordinated stability will be assessed using a sway-meter that measures displacements of the body at the level of the waist
D Scales and Questionnaires
To provide an assessment of changes in the subjects psychological and functional states a stroke impact scale a self-efficacy scale and the health-related quality of life questionnaire will be used
Data Analysis
Treatment efficacy for the primary and secondary outcomes will be analyzed using univariate and multivariate analysis of variance Where within-group differences are found appropriate multiple comparisons a posteriori analyses will be used If significant multivariate effects are evident the standardized discriminant function coefficients will be examined to give an indication of the relative importance of each variable in explaining the variance in the group by time effect To allow for the possibility that all or some of these data may be covariates upon the primary outcome multiple regression analysis will be utilized to explore the relative importance of aerobic fitness muscle power strength or endurance and mobility measures upon 6-min walk distance
1 Participation in a 10-week exercise program consisting of aerobic resistance or combined aerobicresistance training will produce a 20 or greater increase of 6-min walking distance compared to controls
2 Aerobic fitness will increase equally in the combined aerobicresistance program and aerobic program alone greater than that in the resistance program only where effect is measured in terms of maximal and submaximal cardiorespiratory exercise performance
3 Lower limb muscle strength will increase equally in the combined aerobicresistance program and resistance program alone greater than the increase in strength for aerobic training where effect is measured in terms of measures of lower limb strength power and endurance
Research Plan Synopsis
To determine treatment efficacy a 2x2 factorial double-blinded randomized controlled trial will be conducted the two factors being aerobic training and PRT Forty-eight subjects will be randomly allocated to one of four groups comprising i aerobic exercise training AEROBIC n12 ii PRT RESISTANCE n12 iii combined aerobic training and PRT AEROBICRESISTANCE n12 or iv control CONTROLS n12 AEROBIC and RESISTANCE groups will also include a sham treatment for the other factor and the order of presentation of treatment versus sham will also be randomized within each exercise session All subjects will attend 3 times per week for 10 weeks Subjects will be recruited from various hospitals peer support groups and previous participants of an acute stroke research project that we are now conducting All will be screened by a medical practitioner for inclusion and exclusion criteria and then allocated to one of the four groups by the trial coordinator
Interventions
AEROBIC Training Group These subjects will undertake 30 min of leg cycling per exercise session Leg cycling will be performed at a pedaling cadence of 50 revmin in the seated posture using a standard seated cycle ergometer to elicit a target heart rate equivalent to 50 VO2peak - 70 VO2peak Subjects in this group will also undertake 30-min of sham resistance training consisting of stretching and calisthenics lacking any strength development characteristics Cycle ergometry will be used to develop aerobic fitness rather than fast walking because previous studies have shown that stroke patients do not have the capacity to walk at a sufficient pace to provide an adequate stimulus to the cardiovascular system
RESISTANCE Training Group These subjects will undertake 30 min of PRT per exercise session using pneumatic resistance equipment and free weights Standard PRT principles governing frequency volume duration and intensity of exercise known to provide maximal adaptation in both healthy and frail adults will be followed Legs will be trained unilaterally to maximize neural recruitment of the impaired side and prevent substitution of stronger muscles for weaker ones Subjects will perform 3 sets of 8 repetitions at 80 of the one repetition maximum with each muscle group Subjects in this group will also undertake 30-min of sham aerobic training consisting of motorized passive leg cycling
AEROBIC RESISTANCE Training Group Subjects in the AEROBICRESISTANCE training group will undertake 30 min of leg cycling exercise as described for the AEROBIC group in addition to 30 min of PRT as described for the RESISTANCE group per exercise session
CONTROL Group Subjects in this group will undertake 30-min of sham aerobic training consisting of motorized passive leg cycling and 30-min of sham resistance training consisting of stretching and calisthenics lacking any strength development characteristics per session
Outcomes
Primary outcome Subjects will undertake a 6 min walking test for maximum distance The 6-min test has been selected as our primary outcome because walking distance is an important criteria for community ambulation it avoids the problem of gait velocity being relevant only for short-distance ambulation and has a prior history of investigation in previous studies of low intensity aerobic and resistance training
Secondary outcomes
A Cardiorespiratory Fitness will be assessed from cardiorespiratory variables collected during i a maximal effort cycle test ii a multi stage submaximal exercise cycle test and iii a dual stage treadmill walking test performed on separate days
B Lower limb Muscular Strength and Endurance will be assessed from maximal muscle force maximal muscle power and muscle endurance using pneumatic resistance machines leg press knee extension and free weights hip abduction ankle dorsiflexion
C Mobility Variables
Temporal velocity step time single support double support and spatial step length and stride length variables will be collected using a gait analysis system Balance in standing and coordinated stability will be assessed using a sway-meter that measures displacements of the body at the level of the waist
D Scales and Questionnaires
To provide an assessment of changes in the subjects psychological and functional states a stroke impact scale a self-efficacy scale and the health-related quality of life questionnaire will be used
Data Analysis
Treatment efficacy for the primary and secondary outcomes will be analyzed using univariate and multivariate analysis of variance Where within-group differences are found appropriate multiple comparisons a posteriori analyses will be used If significant multivariate effects are evident the standardized discriminant function coefficients will be examined to give an indication of the relative importance of each variable in explaining the variance in the group by time effect To allow for the possibility that all or some of these data may be covariates upon the primary outcome multiple regression analysis will be utilized to explore the relative importance of aerobic fitness muscle power strength or endurance and mobility measures upon 6-min walk distance
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NHMRC 153970 | None | None | None |