Balance Training for Elders With Heart Failure

NCT02566785 | Completed Results

• 1 other identifier: 0677-15-FB
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

Falls are the leading cause of injury-related deaths in older (≥ 65 y/) community dwelling heart failure (HF) patients. Fall risks are even greater for those with HF due to decreased exercise capacity, loss of skeletal muscle \& medication side effects. Though resistance training (RT) is effective for improving skeletal muscle, it has only a modest effect on improving balance, which is comprised of peripheral sensory input central integration, \& motor output. A multi-component intervention focusing on balance retraining \& strengthening the muscles supporting static/dynamic balance \& functional mobility is necessary. This pilot study will evaluate the effect of a multi-component balance \& RT intervention on physical function, balance, \& falls in older (≥ 65 y/) community dwelling heart failure (HF) patients. The study will also explore perceptions related to outcomes \& the intervention through focus groups, generate data on adherence and generate data on feasibility of conducting the BASIC Training intervention. The results of this study will be used to develop a targeted intervention to induce changes in elderly HF patients to prevent future falls; thus reducing costs, physical \& emotional burdens related to falls; \& effect a major difference in the quality of life. The study will be once per week supervised group sessions \& twice a week home sessions, and include 30 Second Sit-to-Stand, Modified Clinical Test of Sensory Interaction on Balance, Activity Specific Balance Confidence Scale, Timed Up \& Go, Dynamic Gait Index.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (2)

• Pre/Post Scores on the 30 Second Sit to Stand Test Will be Used to Detect Any Changes in Leg Strength and Endurance That Occur During the 12 Week Group Exercise Sessions.

  Baseline and 12 weeks

• Dynamic Gait Index

  8 increasingly challenging walking tasks (normal gait speed, changes in gait speed, walking with horizontal and vertical head movements, walking with pivot turn, walking over and around obstacles and stair climbing). A walkway path measured at 20 feet was used. A research assistance observed and scored all participants using a 0-3 scale, 0 = severe gait impairment, 1 = moderate gait impairment, 2 = mild/minimal impairment, 3 = normal gait, with a total possible scale range of 0 to 24 points. Scores ≤ 19 points was used to classify falling risk (Shumway-Cook et al. 1997).

  Baseline and 12 weeks

Secondary Outcomes (1)

• Activity Balance Confidence Scale

  Baseline and 12 weeks

Study Arms (2)

Intervention Group

EXPERIMENTAL

Those allocated to the intervention group will participate in a supervised group session exercise one time per week and be asked to exercise two more times per week at home.

Other: Balance Intervention

Wait List Control Group

OTHER

The wait list control group will not participate in the intervention and will be asked to continue their usual activity level during the first 12 weeks and will receive the multi-component balance intervention during weeks 12-24.

Other: Balance Intervention

Interventions

Balance Intervention OTHER

The multi-component balance intervention will be 1x per week in supervised group sessions and 2x a week sessions at home. Sessions will begin with a 5 minute warm up of major muscle groups using flexibility exercises and end with a cool down. Sessions will focus on improving static balance in the initial stages, then progress to dynamic balance.

Intervention Group; Wait List Control Group

Eligibility Criteria

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

You may qualify if:

• years of age or greater;
• New York Heart Association class II and III,
• community dwelling;
• able to speak and read English,
• must have written permission from cardiologist to participate.

You may not qualify if:

• wheel chair dependency;
• history of significant residual neurologic deficits \[e.g.: recent stroke\];
• recent history of whiplash or concurrent complaints of neck pain;
• recent fracture or lower extremity surgery. Participants will be screened for cognitive dysfunction and must pass the Mini-Mental State Examination \[with a score at or above 23 points\].

Sponsors & Collaborators

• University of Nebraska: lead
• American Nurses Foundation: collaborator

Study Sites (1)

University of Nebraska Medical Center, College of Nursing

Lincoln, Nebraska, 68588-0220, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Dr. Rita McGuire
• Organization: University of Nebraska Medical Center College of Nursing

rita.mcguire@unmc.edu

402-472-4712

Study Officials

• Rita L McGuire, PhD, RN

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2015
• First Posted: October 2, 2015
• Study Start: February 1, 2016
• Primary Completion: December 16, 2016
• Study Completion: December 16, 2016
• Last Updated: September 25, 2023
• Results First Posted: October 9, 2018

Record last verified: 2023-09

Locations

US (1)