Climbing Lifestyle Intervention for Modifying Physical Activity Behaviors: Pilot Study

Quality of Life Clinical Trial

— CLIMB  

Official title:

Climbing Lifestyle Intervention for Modifying Physical Activity Behaviors (CLIMB): Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06368128
• Other study ID #: HS-24_51
• Status: Recruiting
• Phase: N/A
• Start date: April 10, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: Northern Michigan University
• Contact: Lisa Eckert, PhD
• Phone: 906-227-1291
• Email: leckert[@]nmu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this pilot study is to determine the effects of a 12-week indoor rock climbing training program on heart health, mental health, and behavioral health in generally healthy adults aged 18-35 years old who do not exercise. Participants will learn to rock climb using ropes on an indoor rock climbing wall and participate in the training program 2-3 days per week for 60 minutes each session over 12 weeks. Health outcomes will be measured at 4 time points over the course of the study (pre-intervention, 6-weeks/mid-intervention, 12-weeks/post-intervention, and 24-weeks post-intervention).

Description:

The purpose of this study is to determine the effects of a 12-week progressive, supervised indoor rock climbing intervention on physical, mental, and behavioral health outcomes in physically inactive adults. This will be a pilot study used for informing a larger, randomized controlled trial. Measurements include: cardiometabolic disease risk factors (e.g., blood pressure, fasting glucose and lipids, hemoglobin a1c), health-related components of physical fitness (e.g., cardiorespiratory fitness, muscular fitness, dynamic balance, body composition), health-related quality of life, and behavior change variables (e.g., attitudes toward physical activity, self-efficacy for exercise, objective physical activity and sedentary behavior). The majority of rock climbing-related studies focus on enhancing performance in high-level climbing athletes and very little research has examined the specific impact of climbing physical activity on cardiovascular health parameters. Indoor climbing has demonstrated to be an activity that is safe for many individuals and does not require a high level initial fitness to partake in the activity. This study will engage generally healthy, physically inactive adults (aged 18-35 y) in an indoor rock climbing program 2 times per week for 60 minutes for the first 4 weeks and progressing to 3 times per week for 60 minutes for the last 8 weeks. Participants will partake in top-rope style rock climbing and bouldering. Data collection will occur over three visits to the School of Health and Human Performance Research Lab at four time points throughout the course of the study (baseline/pre-intervention, 6-weeks/mid-intervention, 12-weeks/post-intervention, 24-weeks post-intervention; total of 12 data collection visits).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• Physically inactive

• Membership to Physical Education Instructional Facility at Northern Michigan University

• No/very little experience with rock climbing

• No diagnosed cardiovascular, metabolic, renal disease

• No current injury

Exclusion Criteria:

• Physically active

• Experience with rock climbing

• No current membership with Physical Education Instructional Facility at Northern Michigan University

• Pregnant and/or breastfeeding

• Diagnosis of cardiovascular disease, metabolic disease, renal disease

• Current or previous injury that would be exacerbated by rock climbing

• Other diagnosed conditions in which rock climbing would be contraindicated

Related Conditions & MeSH terms

• Lifestyle Factors
• Physical Inactivity
• Quality of Life

Intervention

Behavioral:
• Indoor Rock Climbing Exercise Training Program
Training will occur 2-3 days per week for 60 minutes; ratings of perceived exertion between 3-7 on a scale of 0-10 will be targeted for the desired intensity throughout the program. Minutes of rock climbing will also be monitored to develop the progression strategy.

Locations

Country	Name	City	State
United States	Northern Michigan University	Marquette	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Northern Michigan University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fasting lipids	HDL-c; LDL-c; total cholesterol, triglycerides measured via capillary blood sample and point-of-care testing	0, 6, 12, 24 weeks
Primary	Fasting glucose	glucose (mg/dL) measured via capillary blood sample and point-of-care testing	0, 6, 12, 24 weeks
Primary	Hemoglobin a1c	Glycosylated hemoglobin (%) measured via capillary blood sample and point-of-care testing	0, 6, 12, 24 weeks
Secondary	Physical activity and sedentary behavior	Objectively monitored light, moderate, and vigorous physical activity minutes per week	0, 6, 12, 24 weeks
Secondary	Sedentary behavior bouts (30 min, 60 min, >60 min)	Objectively monitored number of bouts of sedentary behavior occurring in bouts of 30 minutes or less, 30-60 minutes, and greater than 60 minutes	0, 6, 12, 24 weeks
Secondary	Cardiorespiratory fitness	VO2max (mL/kg/min) measured via expired air analysis	0, 12 weeks
Secondary	Muscular fitness	Maximal isometric handgrip strength (kg) using an electronic handgrip dynamometer	0, 12 weeks
Secondary	Handgrip strength asymmetry	Maximal isometric handgrip strength measured using an electronic handgrip dynamometer on both hands	0, 12 weeks
Secondary	Lower-body dynamic balance	Lower-quarter y-balance test distance (cm) on each leg, in the anterior, posteromedial, and posterolateral directions.	0, 12 weeks
Secondary	Health-related quality of life using CDC Health-Related Quality of Life Scale	Core healthy days module, activity limitations module. Core healthy days module measures the number of days over the past 30 days where injury, mental health, was not good and kept individuals from performing usual activities. Activity limitations asks if individuals are limited by any health problems, how many days they are limited by health problems, and if needs are impaired. Healthy days symptom module asks if pain, depression, anxiety and sleep were an issue on any number of days over the past 30 days. Additionally, how many days individuals felt healthy and full of energy over the past 30 days.	0, 6, 12, 24 weeks
Secondary	Exercise self-efficacy measured via Self-efficacy for exercise scale	Self-efficacy for exercise scale is 9 items representing various scenarios that are measured on a scale of 1 (not confident) to 10 (very confident) a participant feels to exercise in that scenario. Higher scores represent higher self-efficacy for exercise participation.	0, 6, 12, 24 weeks
Secondary	Perceptions of exercise measured via Views and Attitudes Toward Exercise Scale	Views and attitudes towards exercise scale is 15 items measured on a 7-point Likert scale from strongly disagree (lowest) to strongly agree (highest). Sum up all responses, higher scores are better perceptions of exercise.	0, 6, 12, 24 weeks
Secondary	Perceived stress	Perceived stress scale items are scored from adding up each alternative over 10 items: 0=never, 1=almost never, 2=sometimes, 3=fairly often, 4=very often. 0-13=low stress, 14-26=moderate stress, 27-40=high perceived stress.	0, 6, 12, 24 weeks
Secondary	Blood pressure	Systolic and diastolic blood pressure (mmHg) measured via automated blood pressure cuff.	0, 6, 12, 24 weeks
Secondary	Body composition	Fat free mass, fat mass in kg using Dual-energy x-ray absorptiometry	0, 12, 24 weeks
Secondary	Bone density	Total bone density (g/cm3) using Dual-energy x-ray absorptiometry	0, 12, 24 weeks