Resistance Training to Improve Strength and Functional Trunk Stability in Adults With Paraplegia

NCT03949699 | Completed

• 1 other identifier: 2015P001481
• Study Type: interventional
• Target: 11
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to examine the effectiveness of an 8- week resistance training routine to improve functional trunk strength, muscle activation, and physical functioning in exercise in 30 adults with paraplegic SCI. This study will also examine outcomes of confidence in one's ability to avoid falling during balance challenges, and self-efficacy for participating in exercise activity.

Conditions

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (2)

• Change in Strength

  Maximum strength: Subjects will be given a set of ten repetitions with a light weight, as a warm-up prior to testing. The weight stack will then be adjusted to a load intended to induce muscular fatigue within ten repetitions. The subject will perform as many complete repetitions as possible. Once the subject fails to perform a repetition through the complete range of motion, they will have reached fatigue, and the weight and number of repetitions will be recorded. If the number of repetitions exceeds ten, then the weight will be increased and the subject will be given a three-minute rest interval before repeating the test. A regression equation 4 will then be used to calculate maximum strength

  . Testing will be repeated at weeks 4 & 8. Maximum strength values established during Baseline and 4th week testing will be used to calculate the exercise workloads for the next four weeks of training

• Change in Balance

  Items from the Activity-based Balance Level Evaluation (ABLE) Sitting Balance subscale: Participants perform the following activities, which are scored according to ability and quality of movement: 1.Sitting with back unsupported but feet supported on floor or on a foot stool; 2. Modified functional reach test; 3. Seated lateral reach; 4. Pick up an object from the floor from a seated position; 5. Scooting forward in a chair; and 6. External perturbations in sitting. This measure typically takes 15 minutes to administer.

  Baseline, and weeks 4 & 8

Secondary Outcomes (3)

• Change in SCI-Functional Index (SCI-FI)

  Baseline and 8 weeks

• Change in Falls Concern Scale for people with SCI (SCI-FCS)

  Baseline and 8 weeks

• Change in SCI Exercise Self-Efficacy Scale (SCI ESES)

  Baseline and 8 weeks

Study Arms (1)

Resistance Training

OTHER

. Participants will engage in strengthening exercises using a cable tower while seated. These movements will include trunk flexion and extension, diagonal trunk rotation, and lateral trunk flexion. The goal for resistance training frequency (Weeks 1-8) will be three times per week, lasting about 30-45 minutes per session including warm-up/cool-down. Performance during exercise sessions will be monitored by study staff who will progress the participant to exercises of greater intensity (increasing number of repetitions, sets, or resistance load; on an individual basis over the 8-week intervention period according to the participant's level of readiness). This progression will also be guided by a strength training protocol. Resistance intensity of each exercise will also be determined based on the initial maximal strength performing that exercise

Other: Resistance training

Interventions

Resistance training OTHER

Participants will engage in strengthening exercises using a cable tower while seated. These movements will include trunk flexion and extension, diagonal trunk rotation, and lateral trunk flexion. The goal for resistance training frequency (Weeks 1-8) will be three times per week, lasting about 30-45 minutes per session including warm-up/cool-down, for a duration of eight weeks. Resistance intensity of each exercise will also be determined based on the initial maximal strength performing that exercise: Weeks 1-4 will be 50-60% of the baseline calculated 1 repetition maximum (RM) values; Weeks 5-8 will use resistive loads equivalent to 50-60% of Week 4 1RM calculations

Resistance Training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be in good health (asymptomatic for acute treatable illness)
• Be able to understand, communicate with and be understood by research personnel and interpreters
• Be interested in participating and provide informed consent
• Have a SCI with residual deficits (AIS A, B, C), and from the neurological level of T2 and lower to allow at least partial use of trunk muscles
• Use a wheelchair as primary means of mobility (≥6 hours/day)

Sponsors & Collaborators

• Spaulding Rehabilitation Hospital: lead

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral Research Fellow

Model Details: pre-post

Study Record Dates

• First Submitted: May 10, 2019
• First Posted: May 14, 2019
• Study Start: November 24, 2015
• Primary Completion: March 19, 2019
• Study Completion: March 19, 2019
• Last Updated: May 14, 2019

Record last verified: 2019-05