NCT00827827

Strength Training for Skeletal Muscle Adaptation After Stroke

Completed NA Results posted Last updated 9 July 2018

What this trial tests

NA trial testing Exercise- Strength Training in Stroke in 38 participants. Completed in 6 June 2018.

Timeline

1 April 2009

Primary endpoint
31 August 2013

6 June 2018

Quick facts

Lead sponsor	VA Office of Research and Development
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	38
Start date	1 April 2009
Primary completion	31 August 2013
Estimated completion	6 June 2018
Sites	1 location across United States

Drugs / interventions tested

• Exercise- Strength Training
• Exercise- Stretching Control

Conditions studied

• Stroke — all drugs for Stroke →

Sponsor

VA Office of Research and Development — full company profile →

Who can join

Adults 40 to 85, any sex, with Stroke. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in 1-repetition Maximum (RM) Muscle Strength (Leg Press, Paretic Side) Primary · Baseline, 3 months

Group	Value	95% CI
Strength Training	126.1	± 22.2
Stretching Control	11.3	± 14.6

Change in 1-RM Muscle Strength (Leg Press, Non-Paretic Side) Primary · Baseline, 3 months

Group	Value	95% CI
Strength Training	93.2	± 26.1
Stretching Control	22.7	± 16.4

Change in 1-RM Muscle Strength (Leg Extension, Paretic Side) Primary · Baseline, 3 Months

Group	Value	95% CI
Strength Training	28.6	± 4.3
Stretching Control	3.4	± 2.4

Change in 1-RM Muscle Strength (Leg Extension, Non-Paretic Side) Primary · Baseline, 3 Months

Group	Value	95% CI
Strength Training	20.8	± 0.4
Stretching Control	0.4	± 2.6

Change in Leg Muscle Endurance (Paretic Side) Primary · Baseline, 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).

Group	Value	95% CI
Strength Training	27.4	± 4.5
Stretching Control	2.0	± 2.1

Change in Leg Muscle Endurance (Non-Paretic Side) Primary · Baseline, 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).

Group	Value	95% CI
Strength Training	27.5	± 5.0
Stretching Control	1.8	± 1.8

Change in 6-minute Walk Distance Primary · Baseline, 3 Months

Group	Value	95% CI
Strength Training	132.3	± 48.3
Stretching Controls	-2.1	± 21.6

Change in 10 Meter Walking Speed (Self-Selected) Primary · Baseline, 3 months

Group	Value	95% CI
Strength Training	0.16	± 0.09
Stretching Controls	0.03	± 0.06

Change in 10 Meter Walking Speed (Fastest) Primary · Baseline, 3 Months

Group	Value	95% CI
Strength Training	0.24	± 0.10
Stretching Controls	0.09	± 0.08

Change in Peak Aerobic Capacity (VO2 Peak) Primary · Baseline, 3 Months

Group	Value	95% CI
Strength Training	1.2	± 0.6
Stretching Controls	-0.4	± 0.5

Change in Berg Balance Scale Primary · Baseline, 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.

Group	Value	95% CI
Strength Training	0.3	± 0.6
Stretching Control	-0.1	± 0.5

Change in Paretic Limb Step Time (Self-Selected) Primary · Baseline, 3 months

This and other measures come from Instrumented Walkway (Gait Rite)

Group	Value	95% CI
Strength Training	-0.04	± 0.03
Stretching Control	-0.03	± 0.03

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Strength Training

Serious: 2/22 (9%)

Deaths: —

Stretching Control

Serious: 2/16 (13%)

Deaths: —

Serious adverse events (3 terms)

Reaction	System	Strength Training	Stretching Control
fell at home	General disorders	—	—
hypotensive episode	General disorders	—	—
choked on a pill at home	General disorders	—	—

Other adverse events (5 terms — click to expand)

Reaction	System	Strength Training	Stretching Control
falls outside of training/ testing sessions	General disorders	—	—
hypotensive event	General disorders	—	—
muscle strain	General disorders	—	—
gout flare-up	General disorders	—	—
adverse reaction to lidocaine during muscle biopsy	General disorders	—	—

Most-reported serious reactions: fell at home, hypotensive episode, choked on a pill at home.

Data from ClinicalTrials.gov NCT00827827 adverse events section.

Sponsor's own description

Chronically disabled stroke survivors experience accelerated skeletal muscle atrophy and other detrimental changes to muscle and surrounding tissues on the paretic side. This unilateral tissue-level damage contributes to worsening disability and insulin resistance. This VA Merit Award will advance the investigators' understanding of the potential for strength training (ST) to reverse stroke-related muscle abnormalities to improve metabolic health, strength, and function. It will be the first study to thoroughly investigate the effects of ST on muscle atrophy, intramuscular fat, muscle fiber characteristics, capillary density and insulin sensitivity after stroke.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Physical fitness training for stroke patients.
   Saunders DH, Sanderson M, Hayes S, Kilrane M, et al · · 2016 · cited 134× · PMID 27010219 · DOI 10.1002/14651858.cd003316.pub6